This one-day workshop aims to provide technologists both new and experienced in cell and gene therapy with fundamental training in cell product manufacturing spanning collections, QC/QA, regulatory, distribution logistics, devices, and insight into working with industry.
FUNdamentals of Cell Product ManufacturingSeparate registration fee required. See below for ratesDate: Saturday May 7, 2022Time: 08:30 - 16:15Two parallel tracks
Continuing Medical Laboratory Education Credits (CMLE)This workshop provides 6 hours of CMLE credits. Upon completion of a short questionnaire, attendees will receive a CMLE certificate to claim their credit hours.
Program Organized By :
Introduction to Cell Therapy Manufacturing: Vein to Vein
Co-Chairs: Wade Atkins & LizetteCaballeroRoom 2A
Cell Therapy Manufacturing: Bench to Bedside
Co-Chairs: Lynn O’Donnell & Diane KadidloRoom 2B
Introduction and OverviewBy Lizette Caballero, BS, MT(ASCP)
• Cell Therapy Terminology• GTP concepts
Introduction and OverviewBy Diane Kadidlo, BSc, MT(ASCP), SBB & Lynn O'Donnell, PhD• 351 vs 361
Session 1: CollectionsBy Federico Rodriguez Quezada, SBB, MLS(ASCP)• Cell sources and how are theycollected: apheresis, bonemarrow, cord blood• Comparison of the different cellsources: apheresis vs bonemarrow vs cord blood• Types of donors: haploidentical,matched related, matchedunrelated• Donor suitability and eligibility
Session 2: Role of Manufacturing in Regulatory SubmissionsBy Kevin Bosse, PhD, RAC• CMC preparation and expectations• Impact of product changes• FDA interactions
Session 3: Manufacturing Devicesby Darin Sumstad, MLS (ASCP)• Current role of cell processing devices inprocess development and clinical manufacturing• Lessons learned: benefits and challenges ofmanufacturing device integration
Biopreservation & Bioproduction Challenges and Best Practices for Cell/Gene Therapy Manufacturing
by Aby J. Mathew, PhD
Session 4: Manufacturing Operationsby Emily Hopewell, PhD• EM & Cleaning: can you have too much of a “good” thing?• Aseptic technique and process-specificcompetency assessments
He successfully challenged the American Society of Clinical Pathologist Specialist in Blood Banking exam in 1995. He earned a Master of Science degree from the University of Maryland University College in 1998.
For the last nineteen years he has worked as a quality assurance and regulatory specialist for the Department of Transfusion Medicine (DTM) for the National Institutes of Health in Bethesda Maryland. He is the current supervisor of a team of five quality specialists. The DTM is a full service blood bank with a licensed collection facility and a full transfusion service.
He often speaks at local, national and international meetings on quality and regulatory related topics for biological products.
For the last 24 years I have worked in the cellular therapy field, first managing the cellular therapy laboratory at Florida Hospital, Orlando, FL (1996-2011), and the Blood and Marrow Transplant (BMT) Laboratory at UCSF, San Francisco, CA (1996-2020). I was responsible for compiling quality control data, assisting in the research and developmental of new instruments and techniques, training employees, and development and revision of laboratory procedures, among other things. I also ensure that our responsibilities include assurance that the Cellular Therapy Laboratory adheres to the rules and regulations of all applicable local, state and federal agencies.
Most recently I join Janssen Pharmaceuticals (Johnson & Johnson) as an Associate Director, CAR T Apheresis Site Liaison (CASL). My position serves as a cross-functional, point of contact within Janssen for operational and technical aspects of collections and cryopreservation of apheresis cells used to manufacture chimeric antigen receptor T cells (CAR-T). The CASL also provides technical and operational support to clinical sites participating in Janssen global CAR-T clinical trials.
I am an active member of the International Society of Cellular Therapy (ISCT) where I’m holding the position of Secretary for the Executive Management Committee for 6 years. I have experience as a FACT inspector for cellular therapy processing facilities, having completed more than 20 inspections during the last 15 years.
Mary has over 25 years of experience in cellular therapy and transfusion service medicine. She earned her Bachelor of Science in Medical Technology from Rush University and Bachelor of Arts in Liberal Arts Monmouth College. Mary later completed the Specialist in Blood Banking program at Barnes Washington University. Mary started at Stanford Health Care in 1994 and she has had a variety of roles, starting as a Cell Therapy Technologist, then Processing Facility Supervisor in 2000, now Quality Manager since 2017. Mary’s experience includes cellular therapy product collection, processing, cryopreservation, regulatory compliance, labeling, process improvement, audits, and quality management oversight. Mary is active with AABB, FACT, and ISCT organizations as a standards board committee member and as an AABB accreditation committee chair. Mary serves as an AABB assessor and as a FACT inspector for cellular therapy facilities and she has conducted over 50 assessments or inspections with these organizations over the past 20 years.
Emily Hopewell began her career at the Moffitt Cancer Center as a technologist in the Cell Therapy Facility in 2003. She received her PhD in Cancer Biology from the University of South Florida in 2012. She joined Indiana University in 2018 and is the Director of Cell and Gene Therapy Manufacturing (CGTM) and an Assistant Professor in Clinical Medical and Molecular Genetics. The CGTM group comprises the Vector Production Facility, Cell Immunotherapy and Transduction Facility, and the Bioprocess Development Laboratory. Dr. Hopewell oversees all aspects of manufacturing, from development efforts to clinical production of cell and gene therapies for use in clinical trials. She provides leadership, strategic direction and input on education, research and clinical missions within the Cell and Gene Therapy GMP Facilities, the Department of Medical and Molecular Genetics, and the Brown Center for Immunotherapy.
Diane Kadidlo is the Director for Molecular and Cellular Therapeutics (MCT) at the University of Minnesota. She is responsible for the clinical manufacturing and product development of biotherapeutic agents produced at MCT. She oversees environmental monitoring, critical systems and all equipment for the MCT facility. She directs the development of research protocols to clinical status with oversight of scale up studies, budget development, project timelines, master batch production records, validation studies and clinical production.
Ms. Kadidlo also serves as the Technical Supervisor of the University of Minnesota Medical Center Cell Therapy Laboratory. The Cell therapy Clinical Laboratory performs somatic cell and tissue graft engineering for hematopoietic transplantation and immune adoptive therapies in support of the University of Minnesota Blood and Marrow Transplant program. She has over 20 years experience in cell and tissue manufacturing, regulation and quality assurance.
Dr. Mathew was part of the founding team of BioLife Solutions, Inc., and is a co-developer of BioLife’s biopreservation media solutions. Dr. Mathew has been researching low temperature biopreservation and stability since 1994, and his studies contributed to the development of BioLife’s commercial HypoThermosol® and CryoStor® product platforms. Dr. Mathew was BioLife’s first Director of Manufacturing, established BioLife’s initial Quality system, and is currently BioLife’s Executive Vice President & Chief Scientific Officer.
Federico Rodriguez Quezada has over 30 years of experience in cellular therapy and immunohematology fields; earned his Bachelor of Science in Medical Technology from the Autonomous University of Nuevo Leon in Monterrey, MX; he attended Specialist in Blood Banking School at the University of Texas Medical Branch in Galveston, TX. He later on became accredited as an SBB by the American Society for Clinical Pathology (ASCP). He has held different positions during his professional career: Medical Technologist, Sales Specialist, Laboratory Supervisor, Education Coordinator, Laboratory Manager, Technical Director, Adjunct Faculty, Coordinator and recently as a Consultant. His experience includes all aspects of manufacturing, regulatory requirements and compliance, process design, process improvement and quality management systems in the Cellular Therapy field, including bone marrow, cord blood and peripheral blood as well as other novel therapies. He has provided guidance to laboratories and institutions worldwide, including the United States, Europe, Latin America and the Middle East. He is an active member of the AABB, ASTCT, ISCT and SCABB; has participated as a member in several Committees within these organizations: Former Chair for the ISCT Laboratory Practices Committee, FACT-Netcord Processing, Selection and Release Standards Subcommittee; FACT Web Oversight Committee, FACT-NetCord Accreditation Committee, FACT International Affiliations Committee; he was also FACT-Netcord assessor for both Processing Laboratories and Collection as well as AABB inspector for Cellular Therapies.
Dr. Lynn O'Donnell is a Professor of Internal Medicine and the Director of Cell Therapy Manufacturing and Engineering at the OSUCCC-James Cancer Hospital & Solove Research Institute. Her research interests include novel cellular therapies for malignancies and regenerative medicine, translational development, GMP manufacturing, IND and IDE submissions for FDA.The OSUCCC-James Cell Therapy Laboratory (CTL) services include processing, testing, storage, distribution and advanced manufacturing of cellular products such as hematopoietic progenitor cells (HPCs), mesenchymal stem cells (MSCs), Natural Killer (NK) cells and T cells. Lynn has been responsible for CTL operations for the past twenty years when she moved from a James-funded research scientist position to full time CTL Director. CTL supports two BMT/CT programs, currently participates in 2-3 dozen cell therapy clinical trials at any given time, and has manufactured investigational cell therapies for over 20 INDs/IDEs.
Darin Sumstad currently serves as a Technical Specialist in the MHealth, Fairview, University of Minnesota Medical Center, Cell Therapy Laboratory. The Cell Therapy Clinical Laboratory performs somatic cell and tissue graft engineering for hematopoietic transplantation and immune adoptive therapies in support of the Blood and Marrow Transplant program.
Graduating in 1999 with a Bachelors of Science degree in Medical Laboratory Science from the University of Minnesota, he has over 20 years of experience in cell and tissue manufacturing. As a Technical Specialist, he is responsible for product development and technology transfer from the research environment to GMP production and during this time has been involved with the successful scale-up and manufacturing of over 50 INDs/IDEs. Mr. Sumstad’s expertise in process optimization expands across a wide array of technologies and cell types ranging from cell expansion and cell and tissue culturing techniques, equipment selection, to cell selection, cryopreservation, QC assay development, and tumor lysate techniques. Past development projects he has worked on include iPSC reprograming and differentiation, natural killer cells, regulatory T cells, mesenchymal stem cells, cardiac derived stem cells, vascular tissue scaffolds, creation of master cell banks and dendritic cell production. His interests include translational development, data management, and cell processing automation.
Dr. Vasovic is Medical Director of the Clinical Cellular Therapy Laboratory at New York-Presbyterian Hospital and Assistant Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine. Dr. Vasovic received her Medical Degree from the School of Medicine University of Belgrade. In addition, she completed an immunology research fellowship at Memorial Sloan Kettering Cancer Center, a Pathology residency at Lenox Hill Hospital, New York University, a Hematopathology fellowship at Albert Einstein College of Medicine and a Transfusion Medicine Fellowship at Harvard Medical School, Joint Program in Transfusion Medicine. His primary research interests include optimizing stem cell products manufacturing for transplant and enhancing quality assurance programs for cellular therapy laboratories.
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