Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Innovation in Filter Validation and Technology TransferMilliporeSigma
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early stage products that do not have the quantity of material required to easily and efficiently perform such testing. Process and product parameters were varied to determine their effect on microbial retention.
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Innovation in Filter Validation and Technology TransferMilliporeSigma
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early stage products that do not have the quantity of material required to easily and efficiently perform such testing. Process and product parameters were varied to determine their effect on microbial retention.
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
Are you looking for an unparalleled solution to reduce in-process volumes within DSP, reach concentrations and yields unachievable with batch TFF, and enable continuous processes? Download the white paper to learn more about SPTFF, a versatile ultrafiltration solution for volume reduction.
Part of the BioContinuum™ Ultrafiltration Platform: www.merckmillipore.com/biocontinuum
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Selection, sizing, and operation of bioprocess filtration trains for optimal ...Merck Life Sciences
To increase filter lifetime and improve the economics of filtering bioprocess streams, a prefilter is often installed upstream of a final sterilizing-grade filter. However, determining the economic optimum prefilter and final filter configuration can be challenging. Numerous prefilter options are available, the prefilter to final filter area ratio must be determined, and operating conditions must be selected that will both satisfy the filtration requirements and provide for an economical process that minimizes the filtration system footprint.
One approach towards achieving an optimal filtration system design is to test the bioprocess fluid with several filter configuration combinations and at a range of operating conditions. However, this can be a daunting task and even impractical given the high cost and limited availability of valuable bioprocess fluids. A better approach is to run a limited filtration trial and use a mathematical model that can accurately predict the behavior of the prefilter and final filter under different conditions.
In this webinar we describe a filtration model and test methodology to rapidly and efficiently design an optimal dual-stage filtration process. The model and methodology were applied to Milligard® PES filters, a new class of autoclavable and gamma sterilizable PES membrane prefilters that are designed to protect microfiltration and nanofiltration final filters in bioprocess streams. We show how a model fit to the data from one set of filtration conditions can be used to predict filtration performance at other prefilter to final filter area ratios and operating conditions, and to determine the economic optimum filtration configuration.
In this webinar, you will learn:
- How filters for microfiltration of biological fluids work.
- The effect of operating conditions on filtration performance.
- How to design an optimal series filtration (prefilter and final filter) process.
How 3D printing is useful for human life's in each aspects of health science and organ development, now a days 3D printing plays a major role because of its vivid uses which helps for human life.
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...Merck Life Sciences
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Increasing the efficacy of drugs and at the same time reducing the chances of adverse reaction should be the aim of drug development, which can be achieved by using 3D printing to fabricate personalized medications
Drugs with narrow therapeutic index can easily be prepared using 3D printing; and, by knowing the patient’s pharmacogenetic profile and other characteristics like age, race etc., optimal dosage can be given to the patient.
3D printing technology is a valuable and potential tool for the pharmaceutical sector, leading to personalized medicine focused on the patients’ needs. It offers numerous advantages, such as increasing the cost efficiency and the manufacturing speed. 3D printing has revolutionized the way in which manufacturing is done. It improves the design manufacturing and reduces lead time and tooling cost for new products.
Process Validation Presentation from BioTechLogicPeter Dellva
Exploring Manufacturing Process Validation - BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources.
Our technical expertise resides in a wide range of biological and oligonucleotide products including recombinant proteins, vaccines and blood products. Through the combined expertise and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:
Process Development and Quality by Design (QbD) including:
Design of Experiments (DOE)
Development Reports
Critical Process Parameter Evaluation
Technology Implementation, Transfer and Scale-up
On-site third party contract manufacturing support
BioAnalytical Services
Process Validation
Biotechnology Project Management
Quality Assurance
Regulatory Submissions
PAI Inspection Readiness (FDA Pre-Approval Inspection Readiness)
An Efficient and cGMP-friendly Solution to Diafiltration for Intensified or C...Merck Life Sciences
View the recording here: https://bit.ly/2M6cTYD
Abstract:
Diafiltration is a critical unit operation in the downstream purification train for nearly all monoclonal antibodies and other therapeutic biomolecules, with a particular application being the final formulation step. It provides a cost-effective, efficient, and robust method for achieving > 3 logs of buffer exchange. As the biomanufacturing industry strives for more efficient and cost-conscious processes and facilities by adapting templates to be more flexible, handle larger batch sizes, require lower plant footprint, and run in an integrated or continuous mode, diafiltration has been one of the last unit operations to change. Updated technologies for chromatography, clarification, and concentration have been developed in recent years, offering significant improvements over their existing batch processing equivalents. However, it has been challenging to develop a similar intensified and continuous technology for diafiltration that exceeds established expectations around unit operation productivity while maintaining a process that is easily implementable and suitable for GMP manufacturing.
Our approach to intensified, continuous diafiltration bases the process design on membrane utilization, as opposed to flux and process time typically used for batch designs. The result is a flexible solution that offers 6-8-fold decrease in membrane area, up to 3-fold reduction in pump passes and a substantial footprint reduction. Buffer usage, extent of buffer exchange, and product yield are equivalent to a traditional constant-volume diafiltration process. The process development approach, system components, and process control rely on well-established methods and technologies, reducing risk during scaleup and manufacturing implementation.
In this webinar, you will learn:
- A new process design for continuous diafiltration and its operational robustness over a 24-hour run
- Benefits of implementing this version of intensified or continuous diafiltration in your process train
3D Printing - shaping the future of formulation developmentMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3pLd4cq
In our webinar we will take you on a journey to discover the latest trends in additive manufacturing for developing pharmaceutical dosage forms. We provide you a fundamental understanding of the different technologies currently evaluated in pharmaceutical industry. A clear definition of the key aspects of the individual technologies ensure a strong basis for future implementation of this technology in pharmaceutical manufacturing.
We will review the existing technologies and outline the potential for the targeted application.
An important aspect will be the filament-based 3D printing technology.
A case study will be presented on how a hot melt extrusion process can be optimized for filament production. Material properties as well as down-stream equipment drive a successful implementation.
We will also present a novel melt-based 3D printing approach, which can directly create the final dosage form out of powder. A drop-based deposition of the polymer melt ensures a new level of accuracy and individualization when it comes to the finishing of the final form.
In this webinar, you will learn:
• Additive manufacturing: Basics and potential application fields
• Overview of existing 3D printing approaches and their relevance in Pharmaceutical Industry
• Background and advantages of extrusion-based 3D printing
• Requirements for FDM (fused deposition modeling) based technologies
• New advanced technical approaches for direct shaping of 3D printed tablets
3D Printing - shaping the future of formulation developmentMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3pLd4cq
In our webinar we will take you on a journey to discover the latest trends in additive manufacturing for developing pharmaceutical dosage forms. We provide you a fundamental understanding of the different technologies currently evaluated in pharmaceutical industry. A clear definition of the key aspects of the individual technologies ensure a strong basis for future implementation of this technology in pharmaceutical manufacturing.
We will review the existing technologies and outline the potential for the targeted application.
An important aspect will be the filament-based 3D printing technology.
A case study will be presented on how a hot melt extrusion process can be optimized for filament production. Material properties as well as down-stream equipment drive a successful implementation.
We will also present a novel melt-based 3D printing approach, which can directly create the final dosage form out of powder. A drop-based deposition of the polymer melt ensures a new level of accuracy and individualization when it comes to the finishing of the final form.
In this webinar, you will learn:
• Additive manufacturing: Basics and potential application fields
• Overview of existing 3D printing approaches and their relevance in Pharmaceutical Industry
• Background and advantages of extrusion-based 3D printing
• Requirements for FDM (fused deposition modeling) based technologies
• New advanced technical approaches for direct shaping of 3D printed tablets
Are you looking for an unparalleled solution to reduce in-process volumes within DSP, reach concentrations and yields unachievable with batch TFF, and enable continuous processes? Download the white paper to learn more about SPTFF, a versatile ultrafiltration solution for volume reduction.
Part of the BioContinuum™ Ultrafiltration Platform: www.merckmillipore.com/biocontinuum
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Selection, sizing, and operation of bioprocess filtration trains for optimal ...Merck Life Sciences
To increase filter lifetime and improve the economics of filtering bioprocess streams, a prefilter is often installed upstream of a final sterilizing-grade filter. However, determining the economic optimum prefilter and final filter configuration can be challenging. Numerous prefilter options are available, the prefilter to final filter area ratio must be determined, and operating conditions must be selected that will both satisfy the filtration requirements and provide for an economical process that minimizes the filtration system footprint.
One approach towards achieving an optimal filtration system design is to test the bioprocess fluid with several filter configuration combinations and at a range of operating conditions. However, this can be a daunting task and even impractical given the high cost and limited availability of valuable bioprocess fluids. A better approach is to run a limited filtration trial and use a mathematical model that can accurately predict the behavior of the prefilter and final filter under different conditions.
In this webinar we describe a filtration model and test methodology to rapidly and efficiently design an optimal dual-stage filtration process. The model and methodology were applied to Milligard® PES filters, a new class of autoclavable and gamma sterilizable PES membrane prefilters that are designed to protect microfiltration and nanofiltration final filters in bioprocess streams. We show how a model fit to the data from one set of filtration conditions can be used to predict filtration performance at other prefilter to final filter area ratios and operating conditions, and to determine the economic optimum filtration configuration.
In this webinar, you will learn:
- How filters for microfiltration of biological fluids work.
- The effect of operating conditions on filtration performance.
- How to design an optimal series filtration (prefilter and final filter) process.
How 3D printing is useful for human life's in each aspects of health science and organ development, now a days 3D printing plays a major role because of its vivid uses which helps for human life.
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...Merck Life Sciences
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Increasing the efficacy of drugs and at the same time reducing the chances of adverse reaction should be the aim of drug development, which can be achieved by using 3D printing to fabricate personalized medications
Drugs with narrow therapeutic index can easily be prepared using 3D printing; and, by knowing the patient’s pharmacogenetic profile and other characteristics like age, race etc., optimal dosage can be given to the patient.
3D printing technology is a valuable and potential tool for the pharmaceutical sector, leading to personalized medicine focused on the patients’ needs. It offers numerous advantages, such as increasing the cost efficiency and the manufacturing speed. 3D printing has revolutionized the way in which manufacturing is done. It improves the design manufacturing and reduces lead time and tooling cost for new products.
Process Validation Presentation from BioTechLogicPeter Dellva
Exploring Manufacturing Process Validation - BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources.
Our technical expertise resides in a wide range of biological and oligonucleotide products including recombinant proteins, vaccines and blood products. Through the combined expertise and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:
Process Development and Quality by Design (QbD) including:
Design of Experiments (DOE)
Development Reports
Critical Process Parameter Evaluation
Technology Implementation, Transfer and Scale-up
On-site third party contract manufacturing support
BioAnalytical Services
Process Validation
Biotechnology Project Management
Quality Assurance
Regulatory Submissions
PAI Inspection Readiness (FDA Pre-Approval Inspection Readiness)
An Efficient and cGMP-friendly Solution to Diafiltration for Intensified or C...Merck Life Sciences
View the recording here: https://bit.ly/2M6cTYD
Abstract:
Diafiltration is a critical unit operation in the downstream purification train for nearly all monoclonal antibodies and other therapeutic biomolecules, with a particular application being the final formulation step. It provides a cost-effective, efficient, and robust method for achieving > 3 logs of buffer exchange. As the biomanufacturing industry strives for more efficient and cost-conscious processes and facilities by adapting templates to be more flexible, handle larger batch sizes, require lower plant footprint, and run in an integrated or continuous mode, diafiltration has been one of the last unit operations to change. Updated technologies for chromatography, clarification, and concentration have been developed in recent years, offering significant improvements over their existing batch processing equivalents. However, it has been challenging to develop a similar intensified and continuous technology for diafiltration that exceeds established expectations around unit operation productivity while maintaining a process that is easily implementable and suitable for GMP manufacturing.
Our approach to intensified, continuous diafiltration bases the process design on membrane utilization, as opposed to flux and process time typically used for batch designs. The result is a flexible solution that offers 6-8-fold decrease in membrane area, up to 3-fold reduction in pump passes and a substantial footprint reduction. Buffer usage, extent of buffer exchange, and product yield are equivalent to a traditional constant-volume diafiltration process. The process development approach, system components, and process control rely on well-established methods and technologies, reducing risk during scaleup and manufacturing implementation.
In this webinar, you will learn:
- A new process design for continuous diafiltration and its operational robustness over a 24-hour run
- Benefits of implementing this version of intensified or continuous diafiltration in your process train
3D Printing - shaping the future of formulation developmentMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3pLd4cq
In our webinar we will take you on a journey to discover the latest trends in additive manufacturing for developing pharmaceutical dosage forms. We provide you a fundamental understanding of the different technologies currently evaluated in pharmaceutical industry. A clear definition of the key aspects of the individual technologies ensure a strong basis for future implementation of this technology in pharmaceutical manufacturing.
We will review the existing technologies and outline the potential for the targeted application.
An important aspect will be the filament-based 3D printing technology.
A case study will be presented on how a hot melt extrusion process can be optimized for filament production. Material properties as well as down-stream equipment drive a successful implementation.
We will also present a novel melt-based 3D printing approach, which can directly create the final dosage form out of powder. A drop-based deposition of the polymer melt ensures a new level of accuracy and individualization when it comes to the finishing of the final form.
In this webinar, you will learn:
• Additive manufacturing: Basics and potential application fields
• Overview of existing 3D printing approaches and their relevance in Pharmaceutical Industry
• Background and advantages of extrusion-based 3D printing
• Requirements for FDM (fused deposition modeling) based technologies
• New advanced technical approaches for direct shaping of 3D printed tablets
3D Printing - shaping the future of formulation developmentMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3pLd4cq
In our webinar we will take you on a journey to discover the latest trends in additive manufacturing for developing pharmaceutical dosage forms. We provide you a fundamental understanding of the different technologies currently evaluated in pharmaceutical industry. A clear definition of the key aspects of the individual technologies ensure a strong basis for future implementation of this technology in pharmaceutical manufacturing.
We will review the existing technologies and outline the potential for the targeted application.
An important aspect will be the filament-based 3D printing technology.
A case study will be presented on how a hot melt extrusion process can be optimized for filament production. Material properties as well as down-stream equipment drive a successful implementation.
We will also present a novel melt-based 3D printing approach, which can directly create the final dosage form out of powder. A drop-based deposition of the polymer melt ensures a new level of accuracy and individualization when it comes to the finishing of the final form.
In this webinar, you will learn:
• Additive manufacturing: Basics and potential application fields
• Overview of existing 3D printing approaches and their relevance in Pharmaceutical Industry
• Background and advantages of extrusion-based 3D printing
• Requirements for FDM (fused deposition modeling) based technologies
• New advanced technical approaches for direct shaping of 3D printed tablets
Continuous manufacturing in solid dose - how to leverage opportunities of thi...MilliporeSigma
Watch this webinar here: https://bit.ly/351wNw5
This webinar on continuous manufacturing in solid dose will discuss challenges of this new technology, point out critical parameters and show how to tackle these by choice of excipients.
Continuous manufacturing in solid dose, more accurately named “continuous tablet manufacturing”, this technology is getting increasing attention in solid dose pharma development. Due to the necessity of profound process stability, this manufacturing mode is very much supported by regulatory authorities. QbD is a must in this case and this reflects the choice of excipients as well. Performance criteria like flow, bulk density and compressibility play an important role. Moreover, this technology shows some specific requirements which are not to achieve by some excipients frequently used before.
In this webinar, you will learn:
• What are the most challenging issues of continuous manufacturing?
• What are the benefits from this technology?
• How to tackle the challenges by excipients?
Continuous manufacturing in solid dose - how to leverage opportunities of thi...Merck Life Sciences
Watch this webinar here: https://bit.ly/351wNw5
This webinar on continuous manufacturing in solid dose will discuss challenges of this new technology, point out critical parameters and show how to tackle these by choice of excipients.
Continuous manufacturing in solid dose, more accurately named “continuous tablet manufacturing”, this technology is getting increasing attention in solid dose pharma development. Due to the necessity of profound process stability, this manufacturing mode is very much supported by regulatory authorities. QbD is a must in this case and this reflects the choice of excipients as well. Performance criteria like flow, bulk density and compressibility play an important role. Moreover, this technology shows some specific requirements which are not to achieve by some excipients frequently used before.
In this webinar, you will learn:
• What are the most challenging issues of continuous manufacturing?
• What are the benefits from this technology?
• How to tackle the challenges by excipients?
Creation of filaments for 3D printing via hot melt extrusion - Evaluating dif...MilliporeSigma
For several years now 3D printing technology has been gaining increasing attention within the pharmaceutical industry. One promising 3D printing technology is the fused deposition modeling where a polymer strand is heated and extruded through a small nozzle followed by a solidification on a build plate. Analyze a study in which the main goal was to evaluate the production of highly loaded (>15% API load), highly homogeneous filaments which shall provide excellent properties for 3D printing applications.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
In this webinar, you will learn:
- The key issues in continuous manufacturing concerning excipients
- How those issues can be addressed
Detailed description:
Continuous manufacturing is a major trend in solid dose formulation. It shows economic and quality benefits, however, hurdles and challenges need to be tackled before getting there. This webinar will address these hurdles and challenges as they relate to excipients.
We will present how continuous manufacturing lines are set up and the benefits users have experienced from them. Feeding of especially small components of formulation combined with bad flow is a major challenge, as well as having a high number of components leading to many feeders. Our answer to these challenges are threefold: betting on multifunctional excipients, and on premixes, either as finished products or as customized projects.
Continuous Manufacturing - Issues and AnswersMilliporeSigma
In this webinar, you will learn:
- The key issues in continuous manufacturing concerning excipients
- How those issues can be addressed
Detailed description:
Continuous manufacturing is a major trend in solid dose formulation. It shows economic and quality benefits, however, hurdles and challenges need to be tackled before getting there. This webinar will address these hurdles and challenges as they relate to excipients.
We will present how continuous manufacturing lines are set up and the benefits users have experienced from them. Feeding of especially small components of formulation combined with bad flow is a major challenge, as well as having a high number of components leading to many feeders. Our answer to these challenges are threefold: betting on multifunctional excipients, and on premixes, either as finished products or as customized projects.
3d printing is a new technique in pharma sector which shows a wide range of advantages like personalised medicine, one step process, reduce errors of production.
it has various methods which are shown in presentation
This presentation describes in detail about 3d printing and various stages in it .. It also describes about organ printing.. how it is used in hummer , M1 tank, Xerox company .. This presentation can be useful to take seminars and paper presentations ..
Nesli Sozer gave a presentation about 3D food printing: A disruptive Food Manufacturing Technology at the 3D Food Printing Conference on 28th of June 2017 in Venlo.
Similar to Latest advancements of melt based 3D printing technologies for oral drug delivery (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...Merck Life Sciences
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMerck Life Sciences
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...Merck Life Sciences
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...Merck Life Sciences
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...Merck Life Sciences
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...Merck Life Sciences
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...Merck Life Sciences
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Insights from a Global Collaboration Accelerating Vaccine Development with an...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing
Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...Merck Life Sciences
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
Regulatory Considerations for Excipients used in Lipid NanoparticlesMerck Life Sciences
Lipid excipients and delivery systems such as lipid nanoparticles (LNPs) are essential for a wide variety of therapeutics including mRNA vaccines and therapeutics and gene therapy.
The purity and safety of novel, synthetic lipid excipients must be demonstrated due to their central role in the function of the drug product, distinct physicochemical properties, and the potential for interaction with other ingredients or the physicochemical environment. These excipients must comply with challenging and complex regulatory requirements, similar to those expected of the active pharmaceutical ingredient itself.
This whitepaper provides an overview of the regulatory classification of lipid nanoparticles, liposomes and novel excipients. Specific requirements outlined in guidance documents are shared along with strategies to stay ahead of emerging regulatory challenges.
To find more information about synthetic lipids for pharmaceutical applications and gene therapy, please visit our website:
https://www.sigmaaldrich.com/DE/en/products/pharma-and-biopharma-manufacturing/formulation/synthetic-lipids
https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/formulation/synthetic-lipids
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Latest advancements of melt based 3D printing technologies for oral drug delivery
1. The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
Latest advancements of
melt-based 3D printing
technologies for oral drug
delivery
Dr. Thomas Kipping, Merck KGaA, Darmstadt, Germany
Dr. Xianghao Zuo, Triastek Inc
2. The life science business
of Merck KGaA, Darmstadt,
Germany operates as
MilliporeSigma in the U.S.
and Canada
5. Overview of 3D printing technologies in the pharmaceutical industry
Introduction
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Powder based systems
▪ Drop on Powder, Binder Jetting (DOP)
▪ Selective Laser Sintering (SLS)
Extrusion based systems
▪ Solid forms: Fused deposition modeling
(FDM)
▪ Semi-solid forms: Pressure assisted
syringe
Liquid based systems
▪ Drop on Drop deposition (DOD)
▪ Stereolithography (SLA)
1
3
3D Printing in the
Pharmaceutical Industry
2
Liquid binder Laser
UV Laser Temperature
Temperature
Graphic modified from Jamróz et al. 3D Printing in Pharmaceutical
and Medical Applications - Recent Achievements and Challenges.
Pharmaceutical research. 2018;35(9):176
5
6. Potential future applications for 3D printing
Introduction
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Rx
Diagnosis
Digital prescription
Design of the tablet
3D printing
Personalized medicine
Targeted therapeutic effect
Concept adapted from Lamichhane et al. Complex
formulations, simple techniques: Can 3D printing
technology be the Midas touch in pharmaceutical
industry? Asian Journal of Pharmaceutical
Sciences. 2019;14(5):465-79.
Pharmaceutical
applications
6
7. Future challenges during formulation development
Introduction
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Permeability
Solubility
BCS
Class I
BCS
Class II
BCS
Class IV
BCS
Class III
35%
30%
25%
10%
5-10%
60 – 70%
5-10%
10-20%
Current distribution of
marketed drug substances
Distribution of drug substances according to their respective BCS
classification modified from Ting et al. Advances in Polymer Design
for Enhancing Oral Drug Solubility and Delivery. Bioconjugate
Chemistry. 2018;29(4):939-52.
Distribution of drug
substances in the pipeline
Bioavailability enhancement is an important topic also for 3D printing applications
7
8. Product characteristics of Parteck® MXP
Introduction
Product Properties
Bulk density (g/mL) 0.53±0.02
Tapped density (g/mL) 0.74±0.02
Particle size (D50) (μm) 60-80
Loss on drying (%) <3.0
Angle of repose (°) 35
Tg
(by DSC)
Tm
(by DSC)
Td
(by TGA)
40-45 °C 170 °C >250 °C
Temperature
Melt Viscosity
D=200 (s-1)
Melt Viscosity
D=1200 (s-1)
210 °C 702 Pa*s 283 Pa*s
230 °C 345 Pa*s 174 Pa*s
Product Properties
Hydrolysis grade (%) 85-89
Solubility (%) (max. in water) 33
Mass average molar mass approx. 32,000
pH-value (4% / water) 5.0-6.5
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
8
Presented values are considered for technical
information only
10. 2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Principle of Arburg Plastic Freeforming (APF)
Advanced melt drop deposition
Process
1. Polymer is melted in a
heated plasticizer barrel
2. Via screw rotation the
material is transported to
the nozzle tip
3. Pressure generation via
translational movement of
the screw
4. Discharge of droplets
controlled via piezo
actuator
Simplified schematic view of the Arburg Plastic Freeforming process (APF)
10
11. Deep dive process development
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Advanced melt drop deposition
Temperature zones [°C]:
200, 190, 180
Simplified geometry
10mm x 4 mm
biplanar
11
12. 2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
SEM images of 3D printed tablets
Melt drop deposition
Infos
▪ SEM Images of 3D
printed tablets
▪ Top- and side view
▪ Strands consist of
individual droplets
▪ High homogeneity of the
process
12
13. Application for tablet developments
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Melt drop deposition
Info
▪ Variation of infill
volume can be used
to individually
adjust the porosity
of the tablets
30% Infill 40% Infill 50% Infill 60% Infill
70% Infill 80% Infill 90% Infill 100% Infill
SEM images of 3DP tablets created with Parteck® MXP (variation of infillvolume))
13
14. 2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Mass distribution
Advanced melt drop deposition
Mass distribution of 3DP tablets (10% loading), (n=6)
Info
▪ Homogenous mass
distributions can be
achieved
▪ Drug loading affects
homogeneity but still
remains within
targeted limits of
pharmacopoeias
14
15. 2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Mechanical stability
Advanced melt drop deposition
Mechanical strength of 3DP tablets (n=3)
Info
▪ Diametral compression
was assessed with a
Texture Analyzer
▪ 3D printed tablets
based on Parteck® MXP
provide a high
mechanical strength
even at low infill
volumes
15
16. 2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Friability
Advanced melt drop deposition
Mechanical strength of 3DP tablets (n=3)
Info
▪ High mechanical
strength also translates
into low friability values
over the entire process
range
16
17. Solubility enhancement
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Advanced melt drop deposition
Info
▪ Successful
amorphization of the
drug within the
polymer melt
Weak base
pKa1 = 3.96 (amine); pKa2 = 6.75
(imine) estimated
BCS class II
mW: 531.4
Aqueous solubility: 0.29 mg/L
17
18. Solubility enhancement
2022-06-23 | Webinar | Latest advancements of melt-based 3D printing technologies for oral drug delivery
Advanced melt drop deposition
Info
▪ Solubility enhancement
can be achieved
▪ Fast release kinetics at
lower infill volumes
Modified dissolution conditions to screen for
supersaturation:
100 ml FaSSiF medium, pH 6.5 at 37 °C,
laboratory shaker at 190 rpm
Sample volume 1ml, analysis via HPLC
18
19. The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
Feasibility Study of Parteck® PVA MXP
Using Melt Extrusion Deposition (MED®)
3D Printing Technology
Xianghao Zuo
23rd Jun. 2022, Nanjing, China
20. The R&D and Manufacturing of Triastek
is based in Nanjing, China.
The Business Department of Triastek is
based in Shanghai, China.
22. MED® 3D Printing Process
Principle of MED® 3D Printing Technology
Melt Extrusion Deposition (MED®) 3D printing is a technology that continuously converts powder
feedstocks into softened/molten states followed by precise layer-by-layer deposition to produce
objects with well-designed geometric structures
• NOT rely on filament
• Lower processing temperature
• NO post-printing process needed
• MED array design enables mass production using multiple materials
to fabricate complex structure
Mixing Melt Extrusion
Deposition
Excipient
API
22 Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
23. Application in Parteck® MXP
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
23
Parteck®
MXP M X P
„Particle technology“-
particle engineered product range
Melt Extrusion PVA
0 100 200 300 400 500 600
0
20
40
60
80
100
Weight
Fraction
(%)
Temperature (C)
MXP
Material PVA MXP
Melting Temperature(℃) 184.72
Glass Transition Temperature(℃) 55.99
Thermal Degradation
Temperature(℃)
247.67
Maximum Daily Exposure(mg) 120
24. Printability Evaluation of PVA MXP
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
24
Material PVA MXP
Printing Temperature(℃) 200
Tablet Dimension(mm) 6×9×0.8
Pilot-Scale MED 3D Printer, hundreds of tablets/day
25. Feasibility Study of Drug-loaded PVA MXP
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
25
Model Drug Felodipine
BCS Class IIb
Log P 3.86
Melting Temperature(℃) 146.94
Glass Transition Temperature(℃) 45.09
Thermal Degradation Temperature(℃) 217.17
26. Amorphous Solid Dispersion of Felodipine in PVA MXP
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
26
Material Weight Ratio Extrusion Temperature(℃) Glass Transition Temperature(℃)
PVA MXP:Felodipine
90:10 200-205-205-205-205-205-205-70 52.24
80:20 200-205-205-205-205-205-205-70 52.59
70:30 190-190-190-190-190-190-190-70 50.70
60:40 190-190-190-190-190-190-190-70 45.53
• The API is amorphous when the content is 40%.
• The API acted as a plasticizer to PVA MXP, lowering the
processing temperature.
27. MED 3D Printing of Felodipine/PVA MXP
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
27
Printing Temperature(℃) 200
Tablet 1 Dimension(mm) 6×9×0.8
Tablet 2 Dimension(mm) 6×9×1.6
Tablet 1
Tablet 2
0
20
40
60
80
100
120
Mass
of
Tablets
(mg)
Tablet 1
Tablet 2
28. Dissolution Study
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
28
900mL at 50rpm, 37 ℃
Tablet 1 Tablet 2
900mL at 50rpm, 37 ℃
29. Product Development: Various Release Units Combined at Will
Applications of MED® 3D Printing Technology
29 Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
0 50 100 150 200 250
0
20
40
60
80
100
%
Drug
Release
Time (min)
Time (min)
0 50 100 150 200 250 300
0
20
40
60
80
100
%
Drug
Release
Time (min)
API 1 API 2
IR ER
0 100 200 300 400 500
0
20
40
60
80
100
%
Drug
Release
Time (min)
0 30 60 90 120 150 180
0
20
40
60
80
100
%
Drug
Release
Time (min)
1
2
3
Control Release Rate Control Release Onset Time Control Release Site
Gastric Retention Immediate Release+ Extended Release Different APIs with Different Release profile
30. Product Development: Combination of APIs/Release Modes/Rates
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
30
Top View
Bottom View
Side View
0
20
40
60
80
100
120
0 1 2 3 4 5 6 7 8
Drug
Release
(%)
Time (h)
Model drug 1
Model drug 2
0
50
100
150
200
250
300
0 6 12 18 24
Concentration
(ng/mL)
Time (h)
Model drug 1
Model drug 2
n=3 beagle dogs, mean + SE
Compartment 2
Compartment 1
Compartment 3
Delay layer
ER Formulation of model
drug 2
IR formulation of model
drug 1
By combining extended release and pulsatile release, multiple APIs with markedly different PK
profiles can be incorporated into a single tablet with once-a-day dosing
31. High-throughput Continuous Manufacturing
Applications of MED® 3D Printing Technology
Feasibility Study of Parteck® PVA MXP Using Melt Extrusion Deposition (MED®) 3D Printing Technology| 23rd Jun. 2022
31
Daily Output (w/packaging): 150-200K tablets (24 hrs CM)
Annual Output: 30-40 million tablets