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01:32:25
Webinar Description:This webinar will discuss the considerations involved in making decisions that impact the cryopreservation needs of a cell therapy drug product encountered during process development. We will discuss the challenges of scale in cell therapy, the gaps in automation and standardization in cryopreservation processes, and showcase technologies that address fill/finish obstacles in the cryopreservation of autologous and allogeneic cell therapies.
Considerations for Cryopreservation Practices in Cell Therapy Fill/Finish ProcessesAn ISCT Process and Product Development WebinarPart 2 of 6 of the ISCT PPD Webinar Series
Sponsored in part by:
Samuel Molina, PhDSr. Scientist – Advanced TherapiesWest Pharmaceutical ServicesExton, PA, USA
Speakers:
Lesley Chan, PhDAssociate Director of Process Sciences & Innovations, bluebird bioCambridge, MA, USA
Lesley leads a team of process development scientists with a goal of developing scalable and robust manufacturing processes for gene-modified hematopoietic stem and progenitor cell therapies. She also leads cross-functional initiatives to implement these next-generation manufacturing processes into the clinic.
Steven Doares, PhD, SVPUS Manufacturing & Site HeadCellectis BiologicsRaleigh, NC, USA
Steve leads the functional teams at Cellectis’ new drug substance/drug product manufacturing plant for allogeneic, off-the-shelf T-cell therapies (UCARTs), located in Raleigh, NC. This state-of-the-art facility was designed to meet both clinical and future commercial drug product production capacity needs for Cellectis’ portfolio of immune-oncology UCART programs.
Dalip Sethi, PhDDirector of Scientific AffairsTerumo Blood and Cell TechnologiesDenver, CO, US
Dr. Sethi currently serves as the scientific and clinical development lead for the Cell Therapy Technologies portfolio at Terumo BCT. He holds a doctorate degree and conducted post-doctoral studies at Thomas Jefferson University, PA, USA. Prior to Terumo BCT, Dalip was engaged in the development of technologies & methods for use in cell therapy applications. Throughout his career, Dalip has authored multiple scientific publications and is a co-inventor on several patents & patent applications.
Jean-Sebastian Parisse, PhDCommercial DirectorAseptic TechnologiesBelgium, EU
Dr. Parisse manages and directs the global sales efforts of Aseptic Technologies; accelerating growth and creating tighter connections between customer requirements and innovation, along with increased service levels, with a special attention to immunotherapies since 2009.