The latest innovations in cell bank manufacturing can help accelerate biologic therapeutics program while reducing risk and simplifying overall strategy. As industry expectations continue to evolve, establishing a well-characterized cell bank requires careful consideration of manufacturing processes, contamination control, testing requirements and regulatory expectations. This webinar explores how closed processing and cell line characterization can support a regulatory-aligned pathway from GMP cell bank manufacturing through comprehensive characterization.
The featured speakers will highlight key enhancements to cell bank manufacturing approaches and explore how closed processing systems support closer alignment with changing industry expectations and reduce contamination risk. The discussion will also cover comprehensive upstream capabilities across cell banking and cell line characterization, providing insight into how these activities can be considered as part of an integrated development strategy.
This webinar will also examine next-generation cell line characterization for master cell banks, based on scientific rigor and appropriate risk assessments that address global regulatory guidance. It will provide pragmatic insights into evolving industry expectations and how innovative technologies, scientific expertise and integrated capabilities can establish a solid foundation for biologics programs.
Register for this webinar to learn how cell bank manufacturing can reduce contamination risk, support comprehensive characterization and strengthen biologics development programs.
Speakers
Angela Waugh, Global Scientific Lead for Manufacturing, MilliporeSigma
Angela has had various roles in her 25 years with MilliporeSigma, from Associate Scientist to Department Manager, and she is currently the Global Scientific Lead for the Manufacturing Value Stream. In this role, she supports the global manufacturing teams and clients and has a strong focus on regulatory compliance. Angela spent time building clinical trial experiences during which she developed a strong knowledge of GMP requirements. She holds a degree in Applied Biosciences from Glasgow Caledonian University.
Leyla Diaz, PhD, Technical Consultant, Scientific and Regulatory Consultancy, MilliporeSigma
Leyla Diaz, PhD, is a Technical Consultant in Scientific and Regulatory Consultancy supporting the BioReliance® Contract Testing Services. She provides scientific and regulatory support in biosafety testing and characterization of biological therapeutic products for global customers. Leyla has 20 years of industry experience in product and assay development of therapeutic antibodies and vaccines. Leyla received her doctorate in Microbiology from the University of Maryland, College Park followed by a postdoctoral fellowship at the University of California, San Francisco.
Who Should Attend?
This webinar will appeal to professionals across the following roles and functions:
- Process Development
- CMC Managers
- Quality Assurance
- Regulatory Affairs
- Quality Control Manager
- Biologics Safety Scientist
- Cell Line Development Scientist
- Analytical Development Scientist
- Product Development Scientist
What You Will Learn
Attendees will gain insight into:
- Comprehensive upstream capabilities across cell banking and cell line characterization
- How to implement the benefits of closed processing in a cell bank project
- Testing requirements for a well-characterized master cell bank and working cell bank, including novel testing strategies using state-of-the-art techniques
- How innovative technologies can help reduce critical-path pressure
Xtalks Partner
MilliporeSigma
MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Our BioReliance® biosafety testing and analytical development services deliver risk-mitigating solutions with technical and regulatory expertise. We partner with clients through the product cycle, from early pre-clinical development through licensed production, to help ensure the safety of the world’s therapeutics.
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