Member Exclusive 2021 Webinar: Apheresis Product Procurement for further manufacturing: Best Practices and cGMP Considerations

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Presented by the ISCT North America Legal & Regulatory Affairs Committee

March 31, 2021

Webinar Description:

Targeted Cellular Collections have been successfully used as the cell procurement method for HPC-A transplants for several years. These starting material products are becoming standard products for further manufacturing into novel biological medicines. With this change, the procurement of standardized, high quality and consistent product yields becomes essential to the manufacturing process. The donors may have underlying medical issues that complicate the apheresis procedure. The underlying disease may affect the approach to automated product collection.

As the market is shifting to more licensed products, the manufacturing records and other clinical care documentation now begin with donor selection, qualification and collection. These processes and procedures are now part of the GMP manufacturing process and regulated by federal requirements for drug manufacturing. This session will review the experience of a collection facility with shifting the mindset from service delivery to manufacturing in a regulated environment as well as sharing best practices for collections for Cellular Therapy products.

After this presentation participants should be able to:

Discuss Peripheral Blood Cells as a source for Cellular Therapy Products
Describe frequently encountered Apheresis issues in this donor population
Manage different documentation and collection practices related to cGMP requirements versus other apheresis procedures.

J. Wade Atkins, MS (Moderator)

QA/RA Supervisor

Department of Transfusion Medicine, Clinical Center, NIH

Ashley Krull, PhD

Associate Director, W.W. Williams Cellular Therapy Laboratory

The Ohio State University

Ashley Krull received her undergraduate degree in Biochemistry from the University of Iowa and her Ph.D. in Neuroscience from the University of Washington. After graduate school, Dr. Krull completed a postdoctoral fellowship in regenerative neurobiology within the Department of Neurology at Mayo Clinic in Rochester, Minnesota. In 2019, Dr. Krull became Mayo Clinic’s second-ever Cellular Therapy Fellow and was granted an extended two-year fellowship, which she completed in 2021. This fellowship program included didactic, experiential, and project-driven training with an emphasis on directorship of a clinical cell therapy laboratory. Subsequently, Dr. Krull held an appointment as Instructor within the Department of Laboratory Medicine and Pathology and served as a senior program coordinator within the Mayo Clinic cellular therapy lab and as a consultant for a joint venture biotechnology company spun out of the lab’s work at Mayo Clinic. In 2022, Dr. Krull moved to The Ohio State University where she currently serves as the Associate Director of Cell Therapy Manufacturing and Engineering. She also holds an appointment of Assistant Professor within the Department of Hematology. Her work focuses on the optimization of manufacturing processes for immune effector cells and the translation of novel cellular therapies into the clinic.