The characterization of cellular source material in the development and manufacture of cellular therapies not only helps us understand the nature of what will become living medicine, but it is also a powerful tool that can improve program and patient outcomes. In this webinar, the expert speaker will present the challenges of sourcing and variability of cellular material and share how characterization assays can mitigate the inherent risks of progressing living cells through development
Citing numerous biologic and environmental influences, the speaker will discuss the many causes of donor and patient cell variability, as well as the consequences that can arise for cell therapy developers. The speaker will then discuss which assays and instrumentation can be used to maintain a robust characterization profile of cellular starting material throughout the development and manufacturing lifecycle.
Register for this webinar today to gain insights into characterizing cellular source material for developing and manufacturing cell and gene therapy-based products.
Speaker
Rubina Pal, PhD, Senior Director of Analytical and Process Development at Comprehensive Cell Solutions, NYBC
Rubina Pal, PhD, Senior Director, Analytical and Process Development, serves as the site head for Comprehensive Cell Solutions’ Houston facility. Prior to this appointment, Rubina served as Director of Analytical Development and Product Characterization for Talaris Therapeutics. At Atara Biotherapeutics, a biopharma company, she contributed to the analytical development of Atara’s ATMP pipeline, as well as the first allogeneic T-cell immunotherapy as Associate Director of Analytical Development. Within the CRO industry, Rubina has worked with many biotech and pharmaceutical companies throughout the drug discovery and development cycle. Rubina has a doctorate in Cell Biology from St. George’s University, University of London.
Message PresenterWho Should Attend?
This webinar will appeal to professionals from biotech organizations that are developing cellular therapies with the following job titles:
- Principal Investigators
- Process Development Directors
- Analytical Development Directors
- Cell procurement professionals
- Quality professionals
- Program Directors
- Lead Scientists
What You Will Learn
Attendees will learn about:
- Intrinsic and external factors that influence cell variability in donors with the desired target profile, and even within a single sample
- Ways that incomplete characterization data can damage outcomes for patients and cell therapy developers
- Data that characterization assays reveal and how that data is used throughout development
- Instruments used to perform characterization and when they are typically implemented in a cell therapy program
Xtalks Partner
Comprehensive Cell Solutions
Founded in 2003 as a business unit of New York Blood Center Enterprises, CCS offers its deep expertise in the development and manufacture of cell and gene therapies, using its GMP and GTP facilities. CCS provides a true vein-to-vein solution, spanning fresh cellular collections and cord blood-derived stem cells as source material, to cell isolation, manipulation and cryopreservation capabilities for preclinical to commercial stage products. CCS boasts a client roster comprised of the world’s leading pharmaceutical companies, innovative biotechnology organizations, and academic medical centers. CCS maintains its headquarters in New York City, where it offers its full service CDMO capabilities from cellular collections and clinical apheresis through manufacturing and cryopreservation. Additional collection suites, apheresis services, and development and manufacturing operations are offered at sites in Providence, RI, Kansas City, MO, St. Paul, MN, Houston, TX and Louisville, KY.
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