1. The document introduces a new automated single cell cloning system called VIPS that gently deposits single cells into wells while concurrently imaging to verify single cell deposition.
2. Test results show the VIPS improves seeding efficiencies and cloning outcomes compared to traditional methods like limiting dilution for various cell lines.
3. The VIPS generates reports with time-stamped images tracking single cells from deposition through colony outgrowth to provide enhanced clonality verification.
Risk Mitigation in Cell Line Development: Regulatory Considerations and Impac...Merck Life Sciences
In this webinar, you will learn about:
- Risk assessment approaches in upstream process development
- How early cell line development stage is linked to subsequent steps in the bioprocess to assure the quality of the final product
- Benefits of having a completely chemically defined cell line development process
Detailed description:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (Chemistry, manufacturing, and controls).
In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform.
Stemline® XF MSC Medium has High Yield and Functionality in the 3 L Mobius® S...MilliporeSigma
Learn about process parameters and growth results of bone marrow-derived hMSCs cultured in Stemline® XF MSC Medium in a 3 L stirred tank bioreactor-microcarrier platform.
Achieving High Yields in Scalable Xeno Free Culture Formats with Mesenchymal ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ryE5ST
Optimize your mesenchymal stem cell growth. Join our webinar to learn more about our GMP-compliant xeno free media formulation that supports high performance expansions and compatibility with scalable xeno free manufacturing conditions.
Optimizing ex vivo cell expansion processes in preparation for clinical use is a critical step in cell therapy manufacturing. Given the curative and lifesaving impacts these therapies can have on patients, overcoming roadblocks with scalability and supply chain, using high quality raw materials are essential for therapeutic access.
The GMP-compliant Stemline® XF MSC Medium and cocktail promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality. This product was designed for derivation and expansion of MSCs using xeno free conditions in planar and microcarrier-based culture platforms, easing the transfer between research, clinical, and manufacturing scale cultures.
In this webinar, you will:
• Explore the current landscape and future trends of cell culture media for adult mesenchymal stem cells
• Discover ways to derive MSC's from Bone Marrow in Xeno Free conditions from static to microcarrier-based suspension culture platforms.
• Learn how Stemline® XF MSC Media provides robust performance and reduces scalability roadblocks
Presented by: Kathleen Ongena, Ph.D., Head of Customer Applications and Mark Ventresco, Cell Therapy Product Manager
Biosafety in Gene Therapy: Applying the latest regulatory guidance for RCL te...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/33WUiqE
Ensuring the safety and quality of your lentiviral vector is of the utmost importance. Attend this webinar to learn about testing strategies to monitor replication competent lentivirus. You will also hear about recent changes in regulatory guidance with regards to sample types and volumes tested.
The use of lentivirus vectors to produce groundbreaking gene therapies is on the rise. Ensuring the biosafety and quality of these vectors is achieved through a multi-tiered testing approach.
For lentivirus-based therapies, generation of replication competent particles is a potential risk. While improvements in design and manufacturing have decreased the probability of producing replication competent viruses, regulatory agencies provide guidelines to test for their presence at multiple stages in production. This webinar reviews the strategies for monitoring replication competent lentiviruses. We describe current methods and address: Sample types, testing volumes, and expected results.
In this webinar, you will learn about:
• The latest FDA regulatory guidelines on replication competent lentivirus (RCL) testing
• Methods used to monitor RCL
• Considerations on sample type and volume requirements
Setting up for successful lot release testing by Edmund AngMilliporeSigma
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...MilliporeSigma
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Risk Mitigation in Cell Line Development: Regulatory Considerations and Impac...Merck Life Sciences
In this webinar, you will learn about:
- Risk assessment approaches in upstream process development
- How early cell line development stage is linked to subsequent steps in the bioprocess to assure the quality of the final product
- Benefits of having a completely chemically defined cell line development process
Detailed description:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (Chemistry, manufacturing, and controls).
In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform.
Stemline® XF MSC Medium has High Yield and Functionality in the 3 L Mobius® S...MilliporeSigma
Learn about process parameters and growth results of bone marrow-derived hMSCs cultured in Stemline® XF MSC Medium in a 3 L stirred tank bioreactor-microcarrier platform.
Achieving High Yields in Scalable Xeno Free Culture Formats with Mesenchymal ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ryE5ST
Optimize your mesenchymal stem cell growth. Join our webinar to learn more about our GMP-compliant xeno free media formulation that supports high performance expansions and compatibility with scalable xeno free manufacturing conditions.
Optimizing ex vivo cell expansion processes in preparation for clinical use is a critical step in cell therapy manufacturing. Given the curative and lifesaving impacts these therapies can have on patients, overcoming roadblocks with scalability and supply chain, using high quality raw materials are essential for therapeutic access.
The GMP-compliant Stemline® XF MSC Medium and cocktail promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality. This product was designed for derivation and expansion of MSCs using xeno free conditions in planar and microcarrier-based culture platforms, easing the transfer between research, clinical, and manufacturing scale cultures.
In this webinar, you will:
• Explore the current landscape and future trends of cell culture media for adult mesenchymal stem cells
• Discover ways to derive MSC's from Bone Marrow in Xeno Free conditions from static to microcarrier-based suspension culture platforms.
• Learn how Stemline® XF MSC Media provides robust performance and reduces scalability roadblocks
Presented by: Kathleen Ongena, Ph.D., Head of Customer Applications and Mark Ventresco, Cell Therapy Product Manager
Biosafety in Gene Therapy: Applying the latest regulatory guidance for RCL te...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/33WUiqE
Ensuring the safety and quality of your lentiviral vector is of the utmost importance. Attend this webinar to learn about testing strategies to monitor replication competent lentivirus. You will also hear about recent changes in regulatory guidance with regards to sample types and volumes tested.
The use of lentivirus vectors to produce groundbreaking gene therapies is on the rise. Ensuring the biosafety and quality of these vectors is achieved through a multi-tiered testing approach.
For lentivirus-based therapies, generation of replication competent particles is a potential risk. While improvements in design and manufacturing have decreased the probability of producing replication competent viruses, regulatory agencies provide guidelines to test for their presence at multiple stages in production. This webinar reviews the strategies for monitoring replication competent lentiviruses. We describe current methods and address: Sample types, testing volumes, and expected results.
In this webinar, you will learn about:
• The latest FDA regulatory guidelines on replication competent lentivirus (RCL) testing
• Methods used to monitor RCL
• Considerations on sample type and volume requirements
Setting up for successful lot release testing by Edmund AngMilliporeSigma
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...MilliporeSigma
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Releasing Your AAV Therapy with Confidence: Regulatory Considerations and Key...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3icKkbZ
Ensuring the safety and quality of your AAV vector is of the utmost importance. Join this webinar for a high-level overview of the regulatory requirements for AAV testing throughout the manufacturing process, as well as a more detailed look at rcAAV and infectious titer assays.
Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy including: high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors.
This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication competent AAV testing and infectious titer determination by TCID50.
In this webinar, you will learn:
• Critical biosafety considerations for AAV vectors based on the latest regulatory guidance
• How replication competent AAV testing fits into your bulk and final release testing package
• The benefits of routine and platform assays over custom assay development
Presented by:
Steven McDade, Senior Technical Specialist, Field Technology Management
Alfonso Lavorgna, Ph.D., Operations Manager, Virology Services
Promises and Challenges of Manufacturing and Testing Viral Producer Cell LinesMerck Life Sciences
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Developing a Scalable Upstream Bioreactor Process for Lentiviral Vector Produ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Jc77
Gene therapies hold the promise to change lives. As your path to patients accelerates, how can you assure the robust process design, intensification and scalability that meets your evolving manufacturing needs? What benefits can a templated process bring to your commercial success?
As gene therapy progresses toward broader clinical and commercial success, the industry is shifting from treating rare conditions to those of larger populations. This requires scalable solutions for process intensification. In this webinar, we’ll discuss scale-up development for a common viral vector in gene therapy, lentivirus, using the VirusExpress™ Lentiviral Production Platform in Mobius® single-use bioreactors. We will highlight critical considerations when moving from bench-scale to clinical scale process design with manufacturability in mind to ensure commercial readiness. Finally, we’ll review the significant benefits of implementing a templated manufacturing process.
In this webinar you will learn:
• Scale-up development of a suspension-based lentivirus production process
• Designing a process that is manufacturing-friendly and supports commercialization
• The benefits of having a templated manufacturing process
Does your cell line have a secret? Avoid surprises with characterizationMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
• The types of tests that are needed to fully characterize your cell banks
• The best tests to use for your particular cell line
• Reasons why a viral contaminant may be missed
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Learn more about the Valitacell fluorescent polarisation based IgG quantification assay 'ValitaTITER' and about our novel ChemStress fingerprinting assay for cell line development. For more information about our products and pricing, please contact info@valitacell.com
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
Presentation at "2016 Osong BioExcellence - Renaissance in Immunotherapy" at South Korea, an event jointly hosted by Kbio Health and Merck on 6th October 2016.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
Use of rapid quality control test methods as alternatives to traditional meth...Merck Life Sciences
Abstract:
As the market for advanced therapy medicinal products (ATMP) matures the complexities of these molecules are evident and challenging when routine standard quality control (QC) testing is applied. Short shelf life from the point of manufacture to administration to the patient results in relatively low volumes for small scale clinical trials or small patient populations. Within a limited time period and with this low product volume, it is necessary to complete required regulatory QC testing, be that for early or late phase clinical trials, or for licensed drug product in a reduced timescale. So, the challenges with QC testing of cell and gene therapies using traditional test methods is time to results, due to short shelf-life, and availability of sufficient sample, due to low production volumes. Over the past years the application of rapid testing of short-life cell and gene therapies that may also help conserve limited product availability have been utilised. Regulatory expectations for using rapid test methods in place of classical or compendial test methods have been defined and this presentation will provide examples and data from our own experience of a range of alternate methods for application to ATMP products.
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
ESACT 2017 Poster - A new cell line development platform for sigh efficiency ...IanTaylor50
Initial data presented on the new VIPS single cell seeding technology was presented in the prestigious ESACT poster sessions in Lausanne by Dr Ian Taylor (15-17th May, 2017)
Poster from the Barcelona Meeting in June 2015.
Shows the following key features:
1. For some cell types, semi-solid can be useful to keep cells from moving during outgrowth
2. Cell Metric can clearly image single cell in SSM on day of seeding
3. Cell Metric can be used for single round of cloning with 3 month time saving in cell line development
Bioreactors are essential in tissue
engineering, not only because they provide an
in vitro environment mimicking in vivo conditions
for the growth of tissue substitutes, but also
because they enable systematic studies of the
responses of living tissues to various mechanical
and biochemical cues.
Releasing Your AAV Therapy with Confidence: Regulatory Considerations and Key...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3icKkbZ
Ensuring the safety and quality of your AAV vector is of the utmost importance. Join this webinar for a high-level overview of the regulatory requirements for AAV testing throughout the manufacturing process, as well as a more detailed look at rcAAV and infectious titer assays.
Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy including: high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors.
This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication competent AAV testing and infectious titer determination by TCID50.
In this webinar, you will learn:
• Critical biosafety considerations for AAV vectors based on the latest regulatory guidance
• How replication competent AAV testing fits into your bulk and final release testing package
• The benefits of routine and platform assays over custom assay development
Presented by:
Steven McDade, Senior Technical Specialist, Field Technology Management
Alfonso Lavorgna, Ph.D., Operations Manager, Virology Services
Promises and Challenges of Manufacturing and Testing Viral Producer Cell LinesMerck Life Sciences
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Developing a Scalable Upstream Bioreactor Process for Lentiviral Vector Produ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Jc77
Gene therapies hold the promise to change lives. As your path to patients accelerates, how can you assure the robust process design, intensification and scalability that meets your evolving manufacturing needs? What benefits can a templated process bring to your commercial success?
As gene therapy progresses toward broader clinical and commercial success, the industry is shifting from treating rare conditions to those of larger populations. This requires scalable solutions for process intensification. In this webinar, we’ll discuss scale-up development for a common viral vector in gene therapy, lentivirus, using the VirusExpress™ Lentiviral Production Platform in Mobius® single-use bioreactors. We will highlight critical considerations when moving from bench-scale to clinical scale process design with manufacturability in mind to ensure commercial readiness. Finally, we’ll review the significant benefits of implementing a templated manufacturing process.
In this webinar you will learn:
• Scale-up development of a suspension-based lentivirus production process
• Designing a process that is manufacturing-friendly and supports commercialization
• The benefits of having a templated manufacturing process
Does your cell line have a secret? Avoid surprises with characterizationMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
• The types of tests that are needed to fully characterize your cell banks
• The best tests to use for your particular cell line
• Reasons why a viral contaminant may be missed
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Learn more about the Valitacell fluorescent polarisation based IgG quantification assay 'ValitaTITER' and about our novel ChemStress fingerprinting assay for cell line development. For more information about our products and pricing, please contact info@valitacell.com
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
Presentation at "2016 Osong BioExcellence - Renaissance in Immunotherapy" at South Korea, an event jointly hosted by Kbio Health and Merck on 6th October 2016.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
Use of rapid quality control test methods as alternatives to traditional meth...Merck Life Sciences
Abstract:
As the market for advanced therapy medicinal products (ATMP) matures the complexities of these molecules are evident and challenging when routine standard quality control (QC) testing is applied. Short shelf life from the point of manufacture to administration to the patient results in relatively low volumes for small scale clinical trials or small patient populations. Within a limited time period and with this low product volume, it is necessary to complete required regulatory QC testing, be that for early or late phase clinical trials, or for licensed drug product in a reduced timescale. So, the challenges with QC testing of cell and gene therapies using traditional test methods is time to results, due to short shelf-life, and availability of sufficient sample, due to low production volumes. Over the past years the application of rapid testing of short-life cell and gene therapies that may also help conserve limited product availability have been utilised. Regulatory expectations for using rapid test methods in place of classical or compendial test methods have been defined and this presentation will provide examples and data from our own experience of a range of alternate methods for application to ATMP products.
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
ESACT 2017 Poster - A new cell line development platform for sigh efficiency ...IanTaylor50
Initial data presented on the new VIPS single cell seeding technology was presented in the prestigious ESACT poster sessions in Lausanne by Dr Ian Taylor (15-17th May, 2017)
Poster from the Barcelona Meeting in June 2015.
Shows the following key features:
1. For some cell types, semi-solid can be useful to keep cells from moving during outgrowth
2. Cell Metric can clearly image single cell in SSM on day of seeding
3. Cell Metric can be used for single round of cloning with 3 month time saving in cell line development
Bioreactors are essential in tissue
engineering, not only because they provide an
in vitro environment mimicking in vivo conditions
for the growth of tissue substitutes, but also
because they enable systematic studies of the
responses of living tissues to various mechanical
and biochemical cues.
A key bottleneck for mammalian cell culture productivity is the extended duration of the process with inoculum seed train and production culture stretching between 4-6 weeks in duration. Introducing flexibility in scheduling and execution of cell culture manufacturing campaigns with via a reduction in process duration can be a key strategy for maximizing facility utilization and facilitating the progression of multiple therapeutics to clinical trials. In this work, we investigated the initiation of CHO cell culture production runs using seed cultures cryopreserved in large disposable bags.
Direct methods of measurement of microbial growth includes various methods of enumeration of both viable and non viable cell also includes growth curve. Helpful for UG and PG programs of microbiology
Building 3D Tissues for Transplantation and Drug ScreeningMelanie Matheu
Until now only the most elite laboratories have been able to build complex high-resolution tissue for drug screening and transplantation. Our technology has made building large 3D tissues as simple as pipetting your favorite cells.
Utilizing Cell Imaging Technology to Shorten Timelines and Reduce Development Resources by Earlier Identification of High Producing Recombinant CHO Cell Lines
Latest guidance from the US FDA o the importance of clonality for mammalian cell banks. This was presented at the Cell Line Development Conference in Amsterdam, 24th April, 2017
US Pharma presentation on clone screen strategy for monoclonality using Solen...IanTaylor50
Presentation by a Cell Metric CLD customer in US about their use of the system in clone screening for cell line development.
This presentation is made available courtesy of Momenta Pharmaceuticals and IBC Conferences
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
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Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Richard's entangled aventures in wonderlandRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.