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Chimeric Antigen Receptor T- Cell therapy (CART): Process, analytical and cryopreservation challenges

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Contributors

  • Zhimei Du

    Zhimei Du earned a Ph.D. from Cornell University Medical College, Immunology Program, studying molecular mechanisms in tumor immunology and autoimmune disease areas. After graduation, she joined Robert G. Roeder’s laboratory at Rockefeller University, studying Genetic & Epigenetic regulation during lymphocyte development. She was later recruited by Regeneron’s bi-specific antibody engineering group. Later, she joined Amgen’s Cell Sciences & Technology department, focusing on cell line and Upstream process development. She then joined Teva Pharmaceuticals building the Upstream development team and labs for innovative biologics pipelines. Currently, she is the director of Bioprocess at Merck, leading cell line development, cell banking, and cell therapy process development functions. She is also the leader and core member of multiple Industrial-wide Consortium teams, setting up a roadmap and establishing industrial common practices in various biotherapeutics development areas.

  • Dhananjay Jere

    Dr. Jere is working presently as a Scientific Ambassador, and Senior Principal Scientist, with Lonza Drug Product Services since 2016. Prior to joining Lonza, he has worked with Roche in Switzerland and US for 7 years. Dr. Jere has over 10 years of parenteral drug product development experience in early and late stage, mainly Biologics and has supported several IND/IMPDs/BAL filings for NBEs. He has also been involved in the development of novel drug delivery systems, ATMPs such as Cell and Gene Therapy Products. Dr. Jere has special expertise in CMC and regulatory requirements for intraocular drug product development and has to his credit over 30 international peered review publications and patents.

December 12, 2019
Thu 12:30 PM EST

Duration 1H 30M

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