The National Center for Therapeutics Manufacturing (NCTM) provides education, training, and outreach programs to support the development of a skilled pharmaceutical workforce. The NCTM offers academic programs including certificates and an Associate of Applied Science degree in Therapeutics Manufacturing. It has classroom and lab facilities for teaching and simulating commercial manufacturing environments. The goal is to develop professionals for biotech and pharmaceutical industries.
Biomanufacturing and Medical Device Manufacturing at Ivy Tech Community Collegebio-link
Dr. Sengyong Lee compares biomanufacturing and medical device manufacturing and talks about the programs for educating students in these areas at Ivy Tech Community College.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
• Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
• Appropriate quality attributes for different raw material uses
• The importance of quality and regulatory documentation provided by the supplier
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
Biomanufacturing and Medical Device Manufacturing at Ivy Tech Community Collegebio-link
Dr. Sengyong Lee compares biomanufacturing and medical device manufacturing and talks about the programs for educating students in these areas at Ivy Tech Community College.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
• Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
• Appropriate quality attributes for different raw material uses
• The importance of quality and regulatory documentation provided by the supplier
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
Quality by Design A Present to Future Perspectiveijtsrd
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. The Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. Mr. Rajesh Dumpala | Ms. Jaini Bhavsar | Mr. Chirag Patil "Quality by Design: A Present to Future Perspective" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd32985.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/32985/quality-by-design-a-present-to-future-perspective/mr-rajesh-dumpala
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
USP <665> draft standard : A rational risk-based approach to characterization...MilliporeSigma
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapyMerck Life Sciences
View our webinar here: https://bit.ly/2lKNdWX
Many different impurities are present in or generated during biotherapy manufacturing. This webinar will address how process contaminates can arise from raw input materials, occur as residual processing agents, or form as reaction by-products. We will review strategies within product characterization to de-risk the manufacturing process, including the use of routine and high complexity assays; and the recommended testing to meet regulatory requirements for clinical submission. Learn methods to avoid costly pitfalls and implement procedures to expedite product quality decisions at critical junctures in your development plan. We will discuss two types of therapies:
Cell & Gene Therapies
Polyethylenimine (PEI) is a transfection agent used in nearly all cell and gene therapy products. We will review the regulations and the liquid chromatography with charged aerosol detection (LC-CAD) methodology to demonstrate PEI removal during the production process.
Monoclonal Antibodies (mAb) and Cell & Gene Therapies
During mAb manufacturing and inherent to Cell & Gene Therapies, a significant proportion of process impurities arise from the host cell used to express the drug. Host cell protein (HCP) impurities, present at PPM-levels, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. We will review why their complex and diverse nature makes them challenging to monitor, and theho best practices, specifically HCP identification by mass spectrometry, for detection.
Learning points:
1. Accurate detection and characterization of residual PEI in cell and gene therapy products
2. Effective detection and characterization of residual host cell proteins (HCP) in mAbs
3. Available technology and assays for quantifying process impurities
4. Current regulatory requirements for detecting, quantifying, and removing process impurities during biotherapy manufacturing
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Tips to choose right biotechnology college in canadajasonw93
A post secondary program in biotechnology prepares students for careers as lab technicians, lab assistants, DNA analysts and quality testing and controlling assistants in food, pharmaceutical and cosmetic industries.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
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
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Fedegari Training & Education 2017 Calendar offers
programs that have been designed specifically to share experiences and allow our customers to develop a much deeper understanding of technologies and products in sterile processing and contamination control.
Quality by Design A Present to Future Perspectiveijtsrd
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. The Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. Mr. Rajesh Dumpala | Ms. Jaini Bhavsar | Mr. Chirag Patil "Quality by Design: A Present to Future Perspective" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd32985.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/32985/quality-by-design-a-present-to-future-perspective/mr-rajesh-dumpala
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
USP <665> draft standard : A rational risk-based approach to characterization...MilliporeSigma
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapyMerck Life Sciences
View our webinar here: https://bit.ly/2lKNdWX
Many different impurities are present in or generated during biotherapy manufacturing. This webinar will address how process contaminates can arise from raw input materials, occur as residual processing agents, or form as reaction by-products. We will review strategies within product characterization to de-risk the manufacturing process, including the use of routine and high complexity assays; and the recommended testing to meet regulatory requirements for clinical submission. Learn methods to avoid costly pitfalls and implement procedures to expedite product quality decisions at critical junctures in your development plan. We will discuss two types of therapies:
Cell & Gene Therapies
Polyethylenimine (PEI) is a transfection agent used in nearly all cell and gene therapy products. We will review the regulations and the liquid chromatography with charged aerosol detection (LC-CAD) methodology to demonstrate PEI removal during the production process.
Monoclonal Antibodies (mAb) and Cell & Gene Therapies
During mAb manufacturing and inherent to Cell & Gene Therapies, a significant proportion of process impurities arise from the host cell used to express the drug. Host cell protein (HCP) impurities, present at PPM-levels, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. We will review why their complex and diverse nature makes them challenging to monitor, and theho best practices, specifically HCP identification by mass spectrometry, for detection.
Learning points:
1. Accurate detection and characterization of residual PEI in cell and gene therapy products
2. Effective detection and characterization of residual host cell proteins (HCP) in mAbs
3. Available technology and assays for quantifying process impurities
4. Current regulatory requirements for detecting, quantifying, and removing process impurities during biotherapy manufacturing
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Tips to choose right biotechnology college in canadajasonw93
A post secondary program in biotechnology prepares students for careers as lab technicians, lab assistants, DNA analysts and quality testing and controlling assistants in food, pharmaceutical and cosmetic industries.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
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
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Fedegari Training & Education 2017 Calendar offers
programs that have been designed specifically to share experiences and allow our customers to develop a much deeper understanding of technologies and products in sterile processing and contamination control.
Autologous and Allogeneic Cell Therapy Industrialisation – Overcoming Clinical Manufacturing Hurdles Early
A presentation by Chief Operating Officer, Dr Stephen Ward
By choosing Covance as a single, centralized CMC analytical laboratory, you can obtain higher quality analytical data more efficiently and at lower cost/fewer resources than by working with multiple providers/CMOs. This analytical data is the key to knowledge and quality risk management throughout the product lifecycle.
The conference will provide an interactive networking forum to both further develop and answer your queries through a vibrant exhibition room full of technology providers showcasing their technologies and other solutions, poster presentation sessions, expert led case study presentations, a high-level panel discussion, a round table discussion session, and interactive Q&A sessions from a 40-strong speaker faculty examining topics on 4 separate tracks outlined below.
Fedegari Training & Education Calendar 2016Fedegari Group
Fedegari Training & Education Calendar 2016 offer
programs that have been designed specifically to share experiences and allow our customers to develop a much deeper understanding of technologies and products in sterile processing and contamination control.
Commissioning, Qualification and Validation (CQV) - Reasons to WorkOlivia Wilson
CQV stands for Commissioning, Qualification and Validation which is a significant area of the business. Engineers find lucrative career options here in CQV and people seem very much interested in building commissioning firms. To better understand the CQV or Commissioning, Qualification and Validation, click here: https://www.global-cxm.com/commissioning/
Supplements that provide funding to SBIR phase II awards for hiring students, veterans, and college instructors, and partnering with community colleges.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
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Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
National center for therapeutics manufacturing m.pishko ccp13
1.
2. • Academic Degrees
• Certificate Programs
• Professional Development
• Industry Short Courses
• Workshops
• STEM Outreach Programs
• Internships
PROGRAMS
To provide therapeutics manufacturing
education, training, and outreach programs
to support the development of an educated
and skilled pharmaceutical workforce
proficient in process development,
production systems, standard operating
procedures, and regulatory guidelines.
MISSION
NCTM
3. NCTM EDUCATIONAL FACILITY FEATURES:
NCTM
• Two teaching wet labs accommodating 40 students each
• A cell culture facility
• A 50 work station computer laboratory
• A 3,500 sq. ft. cubicle study/teaming area
• Locker facilities for 100 students
• Two large lecture halls for students & conferences
• A mock cGMP process suite with gowning facilities,
Sartorius and GE bioreactors, and AKTA skids to simulate a commercial environment
The National Center for Therapeutics
Manufacturing (NCTM) is a multi-disciplinary
workforce education and biopharmaceutical
manufacturing center focused on developing
skilled professionals for existing and emerging
biotech and pharmaceutical industries. The
NCTM is located on the Texas A&M University
campus in College Station, Texas.
4. NCTM PROGRAM DEVELOPMENT ACTIVITIES
NCTM
For more information about therapeutics
manufacturing programs and training,
please visit our website at:
http://nctm.tamu.edu/
Texas Workforce
Commission
grant awarded
DECEMBER
Phase I:
Curriculum
assessment
& industry
surveys
All core
curricula
complete
MARCH
Initiated
Internship
Program
FEBRUARY
Phase III:
Curriculum
development
JUNE
Established
program
advisory
board
MAY
MARCH
Phase II:
SME kick-off &
course pre-work
Phase IV:
Course
finalization
& submission
JANUARY
2010 20122011
Began
outreach
activities
OCTOBER
Hosted
inaugural STEM
summer camps
JUNE
Facilities
equipping and
preparedness
FALL
Pilot short
courses to
begin
2013
SPRING
SACS approved
associate
programs
JULY
6. NCTM ACADEMIC PROGRAMS
Undergraduate Certificate in
Therapeutics Manufacturing
Associate of Applied Science (AAS)
Degree in Therapeutics Manufacturing
Advanced Technical Certificate in
Therapeutics Manufacturing
Available now Available now Under development
A 12 credit hour certificate that educates
engineering baccalaureate graduates on how to
economically, ecologically, and safely design
and operate equipment used for the production
and separation of biological materials.
A 69 credit hour degree designed to be completed
in two years. This AAS degree offers enhanced
training in cGMP, quality assurance and control,
and biomanufacturing processes necessary for
pharmaceutical production.
A 21 credit hour certificate which will allow
qualified students with an aligned associate or
bachelor’s degree to pursue a short-track
educational path for immediate employment in
the therapeutics manufacturing environment.
Required Course: Required Courses: Required Courses:
MATH 1314: College Algebra BITC 1411: Introduction to Biotechnology
CHEM1411: General Chemistry I
BITC 1411: Introduction to Biotechnology
Choose One Additional Required Course: BIOL 1406: General Biology I BITC 2371: Facility Operations and Safety
BITC 2371: Facility Operations & Safety
BMEN 282: Engineering Biology BITC 2431: Cell Cultures Techniques
CHEN 382: Bioprocess Engineering BIOL 2421: Microbiology
Choose Two Electives:
CHEN 436: Systems Biology
ISEN 303: Engineering Economical Analysis
Speech Elective
BITC 2374: Drug Product Manufacturing
CHEN 489/BAEN 489: Bioreactor Design BITC 2431: Cell Culture
CHEN 489: Bioprocess Control BITC 2411: Biotech Lab Instrumentation
CHEN 489: Designing for Flexibility BITC 2373: Drug Substance Manufacturing
Social Science Elective
ENGL 1301: Composition & Rhetoric
BITC 2471: cGMP Procedures &
Humanities Elective
BITC 2386: Internship in Therapeutics
Manufacturing
BITC 1371: Introduction to Therapeutics
Manufacturing
BITC 1375: Quality Systems for
Therapeutics Manufacturing
BAEN 302: Biological and Ag Engineering
Fundamentals II
CHEN 489/BAEN 489: Introduction to
Bioseparations
BITC 1371: Introduction to Therapeutics
Manufacturing
BITC 1302: Biotechnology Laboratory
Methods & TechniquesCHEN 471/BAEN 471: Introduction to
Biochemical Engineering BITC 1375: Quality Systems in Therapeutics
Manufacturing
ISEN 360: Lean Thinking/Lean
Manufacturing in Biotechnology
BITC 1191: Special Topics in Therapeutics
Manufacturing
CHEM2470: Introduction to Organic &
Biochemistry
CHEN 489: Safety in Pharmaceutical and
Biotechnology Industries
BITC 2471: cGMP Procedures and
Documentation
NCTM partners with a consortium of
educators, including Texas A&M
University, Blinn College, and the Texas
A&M Engineering Extension Service, to
provide these programs.
Available to students beginning in Fall
2013.
Program provides
>110 contact hours
of technical instruction
NCTM provides a broad spectrum of
educational opportunities, including
contract short courses, certificate and
degree programs.
7. I’m Contagious…
…but I’m developing the cure!
This week-long camp is designed to provide high school students with an introduction to the
pharmaceutical industry. We examine the R&D-to-commercialization pipeline that brings
a medical discovery to the market. Campers have the opportunity to participate in exciting
hands-on laboratory projects, like working with recombinant DNA. They also experience
behind-the-scenes activities at local biotechnology and pharmaceutical companies and some of Texas
A&M’s most elite centers, to learn more about careers in research, engineering, and biomanufacturing.
NCTM STEM SUMMER CAMP
June 4-8, 2012 and June 18-22, 2012
NCTM
9. Subcontracting
Produce Implementation
Schedule
Assign Program Personnel
Identify Specific
Workforce Needs for
CIADM
Q4
Q1
2012 2013
Phase III Complete
Begin Phase IV:
Finalization of
CoursesQ1
Pilot Short Courses on
Existing Curriculum
Begin Phase II:
Curriculum Development
for New TrainingQ2
Phase II Complete
Equipment Purchases
Complete
Begin Phase III:
Curriculum Enhancement
/Expansion
Q3
2014
Distance Learning
Education Development
Workforce Training
Continues
Internship Program
ContinuesQ3
Phase IV Complete
Pilot Training on All
Curriculum (Existing &
New)
Program Maintenance
Q2
Repeat Cycle for
Continual
Improvements
Maintain
Workforce
Readiness Efforts
Q4Initiate Recruitment
Campaign
Expand Advisory Board
Internship Program
Expansion & Piloting
Phase I Complete
Training Needs Assessment for
CIADM Workforce
Begin Phase I: Curriculum
Inventory & Assessment
Purchase Equipment
& Supplies
Assign Instructional Personnel
CIADM WORKFORCE DEVELOPMENT PROGRAM
AUG 2012 – Texas A&M Engineering Experiment Station (TEES) was approved by the Department of
Health and Human Services and awarded a $22.7 million subcontract by the A&M System to lead and
manage the therapeutics manufacturing and advanced development workforce training programs for
the Texas A&M Center for Innovation in Advanced Development and Manufacturing.
Q4
