Storage of Cellular Therapy Products: Issues Related to Duration, Discard and Quarantine

Sponsored by the ISCT Lab Practices Committee
October 22, 2008
12pm ET

Co-Chairs: Leigh Sims-Poston, MT(ASCP), Michele W. Sugrue, MS, MT(ASCP)SBB

Speakers:

• Linda L. Kelley, PhD, Director, Cell Therapy Facility - University of Utah Cell Therapy Facility
• Vincent F. La Russa, PhD, Director, Cell Processing Laboratory - Memorial Sloan-Kettering Cancer Center
• Phyllis I. Warkentin, PhD, Director, Transfusion and Transplantation - University of Nebraska Medical Center

Objectives :

1. Review points to consider in developing storage duration and product disposal policies/documents.
   • Identify key legal aspects to incorporate into the documents.
   • Present document examples for review.
2. Review the QC/QA aspects of product disposal to include product traceability, accountability and cross check.
   
   • Review the applicable standards from accreditation agencies.
   • Provide examples or suggestions for guidance.
3. Identify/Review GTP/GMP requirements for product quarantine.
   
   • Discuss strategies for quarantine applications in both small and large cellular therapy programs
   • Provide guidance for inventory management strategies.
4. Identify concepts for active storage and long term storage.
5. Review a program's "real world" approach to long term ''off-site'' storage

Demystifying FDA’s requirements: How to review and implement cell therapy regulations and guidance

ponsored by the ISCT North America Legal and Regulatory Affairs Committee
September 10, 2008
12pm ET

Speakers:

• Fran Rabe, Quality Assurance Manager, Molecular and Cellular Therapeutics, University of Minnesota
• Elizabeth J Read, MD, Director, Cell and Tissue Therapies, Blood Systems Research Institute Clinical Professor of Laboratory Medicine, University of California

Objectives:

1. Differentiate between the FDA’s interim, proposed, final rules and guidance documents
2. Understand how to review a FDA document for pertinent information
3. Define the importance and process for sending document comments to the FDA
4. Will provide practical review examples of a recent FDA Guidance Document

Contamination Control by Design

Sponsored by the ISCT North America Legal and Regulatory Affairs Committee
July 16, 2008
12pm ET

Chair: Andrew Walton, Research Compliance Officer, UC Irvine School of Medicine

Speakers:

• Janett Gray, Director of Quality Assurance, Cognate BioServices - Memphis
• David Betts, Director of Quality Control, Cognate BioServices - Memphis

Objectives:

1. Introduction to contamination control in cellular processing and manufacturing.
2. Understand contamination control by design - not testing.
3. Overview of FDA requirements of contamination control as defined in the Code of Federal Regulations to include 21CFRs 211, 820, and 1271.
4. Present elements of contamination controls – the synergy of facilities design, equipment, procedures to include aseptic processing, personnel training, and environment monitoring.
5. Provide suggested actions if contamination does occur.

Quality Systems: Implementation and Oversight

Sponsored by the ISCT Lab Practices Committee
June 11, 2008
4pm ET

Speakers:

• Federico Rodriguez MT, (ASCP), SBB, Technical Director Stem Cell Processing Laboratory, Blood Systems Laboratories, Tempe, Arizona
• Pam Dyson BSc (Hons), Scientific Manager, Therapeutic Products Facility, Haematology Division, IMVS, Adelaide, Australia.

Objectives:

1. Review the requirements of a quality system required to achieve GMP in the manufacture of cellular and tissue products
2. Define the role of documents and records in the effectively implementing a GMP culture
3. Review the staff training, roles and responsibilities required for an effective quality system
4. Understand how to implement change in a GMP culture
5. Understand the critical role of internal/external audits in the oversight of a quality system

Allogeneic versus Autologous Cell Therapy: Challenges and Differences

Sponsored by the ISCT North America Legal and Regulatory Affairs Committee
April 30, 2008
12pm ET

Chair: Grace Kao, MD, Instructor in Pahtology, Harvard Medical School, Assistant Medical Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute

Speakers:

• Grace Kao, MD, Instructor in Pahtology, Harvard Medical School, Assistant Medical Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute
• Olive J. Sturtevant, MHP, MT(ASCP) SBB / SLS, Quality Assurance Manager, Cell Manipulation Core Facility, Dana-Farber Cancer Institute

Objectives:

1. Review the common and emerging types of cell based therapy used in autologous and allogeneic settings
2. Differentiate the clinical risks associated with autologous and allogeneic products
3. Outline the regulatory requirements for autologous and allogeneic products
4. Describe the differences in microbial contamination observed in autologous and allogeneic products
5. Provide examples of how cell therapy related adverse reactions and deviations are handled in an academic cell processing laboratory

Cellular Therapy Products: Lot Release Testing

Sponsored by the ISCT North America Legal and Regulatory Affairs Committee
March 19, 2008
12pm ET

Chair: Shirley Bartido, PhD, QAManager, Gene Transfer & Somatic Cell Engineering Facility, Memorial Sloan Kettering Cancer Center

Speakers:

• Shirley Bartido, PhD, QAManager, Gene Transfer & Somatic Cell Engineering Facility, Memorial Sloan Kettering Cancer Center
• Adrian Gee, PhD, QA Director, Center for Cell and Gene Therapy, Baylor College of Medicine, TX

Objectives:

1. Understand the specifications for testing and release for distribution of cellular therapy products as defined in 21CFR 211.165
2. Understand the importance and rationale in defining sampling and testing plans as it relates to the type of cellular therapy product.
3. Understand the effect of extent of manipulation as seen in 351 vs 361 cellular therapy products on product release testing.
4. Understand the role of QA/QC in complying with cGMP during Phase 1 in terms of lot release testing.
5. Provide a list of guidance documents that are relevant in establishing the specifications for product characterization and safety testing.