Research and Progress Session (RAPS) - Apheresis and Stem Cell Processing for Novel Biotherapies

Sunday, October 20, 2024

5:15 PM - 6:45 PM

Location: 332

Program Chair(s)

Suzanne Thibodeaux, MD, PhD, CABP(H) (she/her/hers)

Associate Professor
Washington University School of Medicine
St. Louis, Missouri, United States

Disclosure(s): Beam Therapeutics: travel expenses to investigator's meeting (Terminated, September 11, 2023)

PDF

Speaker(s)

TH

Tracey Hlucky

Senior Manager, QA
Kite Pharma, a Gilead Co

Disclosure information not submitted.
KL

Kevin J. Land, MD

VP Clinical Services
Vitalant
Tempe, Arizona, United States

Disclosure information not submitted.
SA

Scott Avecilla

Weill Cornell Medicine
New York, New York, United States

Disclosure information not submitted.
Kyle Annen, DO, CABP, QIA (ASCP) (she/her/hers)

Medical Director of Apheresis and Cellular Therapy
Department of Pathology, University of Colorado-Anschutz School of Medicine
Denver, Colorado, United States

Disclosure(s): QuidelOrtho: Honoraria (Terminated, December 31, 2023)
TT

Thomas Z. Thompson, M.D., CABP

Mayo Clinic, Florida, United States

Disclosure information not submitted.
MA

Monica Avila, MT (ASCP)

Sr. Director
CMC Alliance &Project Management at Cellenkos Inc

Disclosure information not submitted.

Disclosure(s):

Suzanne Thibodeaux, MD, PhD, CABP(H): Beam Therapeutics: travel expenses to investigator's meeting (Terminated, September 11, 2023)

Kyle Annen, DO, CABP, QIA (ASCP): QuidelOrtho: Honoraria (Terminated, December 31, 2023)

Apheresis and Stem Cell Processing for Novel Biotherapies

Academic medical centers who run stem cell collection or cellular therapy processing laboratories are increasingly encountering the need to accommodate many different individual protocols for collection or processing of novel biotherapy products (both licensed products and research products). This problem is expensive and labor-intensive to address, and often there is little-to-no return on investment. This session will present the current challenges and provide different approaches to meet these challenges, including two academic medical center perspectives (apheresis and cellular therapy processing), a blood supplier perspective, and industry perspectives.

Learning Objectives:

Describe the current challenges in accommodating the varied and detailed protocols required by industry for CAR-T cell and other biotherapy product collection and processing.
Compare the needs of the collection and processing facilities with the needs of the manufacturing facilities.
Identify cost-effective and practical solutions to meet the requirements for all parties involved in novel biotherapy manufacturing.