Demand is growing for mammalian cell banking in support of the cell and gene therapy field, following strict GMP regulations and tight timelines, to bring the novel biologic products to market faster. It is important to understand the difference between cell banking in support of traditional biologics, such as monoclonal antibodies using CHO cells, and cell banking in support of viral vector manufacturing.

During this webinar, our experts will focus on mammalian cell banking and cell line characterization with a deep dive into CHO and HEK293 cells, including:

Current and future needs for cell banking in support of biologics manufacturing including cell and gene therapies
The expectations around production and testing of producer cells or cells for transfection as they compare to CHO cells for biologics manufacturing
Cell line manufacturing documentation, best practices, and necessary compliance controls
Considerations for characterization and release testing of production cells banks

Presenters:

	Marian L. McKee, Ph.D. Vice President of BioSafety Testing Eurofins BioPharma Product Testing
Marian L. McKee, Ph.D. is Vice President of BioSafety Testing at Eurofins BioPharma Product Testing in Lancaster, PA, USA. She lends her industry experience to support traditional biosafety testing. In addition, she focuses on the development and strategic insight into the company’s gene and cell therapy offering. Dr. McKee holds a B.S. in Zoology from Duke University and a Ph.D. in Microbiology and Immunology from Uniformed Services University of the Health Sciences. She was a CRTA Postdoctoral Fellow at the National Cancer Institute, NIH.
	Raymond Nims Consultant RMC Pharmaceutical Solutions
Raymond Nims brings over 37 years of experience in the biomedical sciences. He currently provides consulting services as an employee of RMC Pharmaceutical Solutions. From 2006 to 2009, Ray served in Amgen’s corporate Quality Control group, providing subject matter expertise in viral and mycoplasma testing of raw materials and products, and serving as business process owner for Amgen’s global contract analytical testing lab outsourcing program. From 1994 to 2006, Ray directed laboratories at BioReliance performing viral safety, endotoxin, and cell line identity studies for biologics cell line characterization, raw material testing, and product lot release testing. Raymond obtained a PhD in chemistry (chemical toxicology) at The American University, Washington, DC, in 1993. He currently serves on the editorial board for the BioProcessing Journal, and has served on the ad hoc advisory boards for USP chapters 1237, 1050, and 1050.1. He is a generalist in the biomedical sciences, with a publication list spanning a wide range of areas in chemistry, carcinogenesis, biochemistry, pharmacology, toxicology, and virology.

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During this webinar, our experts will focus on mammalian cell banking and cell line characterization with a deep dive into CHO and HEK293 cells, including:

Current and future needs for cell banking in support of biologics manufacturing including cell and gene therapies
The expectations around production and testing of producer cells or cells for transfection as they compare to CHO cells for biologics manufacturing
Cell line manufacturing documentation, best practices, and necessary compliance controls
Considerations for characterization and release testing of production cells banks

Presenters:

	Marian L. McKee, Ph.D. Vice President of BioSafety Testing Eurofins BioPharma Product Testing
Marian L. McKee, Ph.D. is Vice President of BioSafety Testing at Eurofins BioPharma Product Testing in Lancaster, PA, USA. She lends her industry experience to support traditional biosafety testing. In addition, she focuses on the development and strategic insight into the company’s gene and cell therapy offering. Dr. McKee holds a B.S. in Zoology from Duke University and a Ph.D. in Microbiology and Immunology from Uniformed Services University of the Health Sciences. She was a CRTA Postdoctoral Fellow at the National Cancer Institute, NIH.
	Raymond Nims Consultant RMC Pharmaceutical Solutions
Raymond Nims brings over 37 years of experience in the biomedical sciences. He currently provides consulting services as an employee of RMC Pharmaceutical Solutions. From 2006 to 2009, Ray served in Amgen’s corporate Quality Control group, providing subject matter expertise in viral and mycoplasma testing of raw materials and products, and serving as business process owner for Amgen’s global contract analytical testing lab outsourcing program. From 1994 to 2006, Ray directed laboratories at BioReliance performing viral safety, endotoxin, and cell line identity studies for biologics cell line characterization, raw material testing, and product lot release testing. Raymond obtained a PhD in chemistry (chemical toxicology) at The American University, Washington, DC, in 1993. He currently serves on the editorial board for the BioProcessing Journal, and has served on the ad hoc advisory boards for USP chapters 1237, 1050, and 1050.1. He is a generalist in the biomedical sciences, with a publication list spanning a wide range of areas in chemistry, carcinogenesis, biochemistry, pharmacology, toxicology, and virology.

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