ROUNDTABLE The Threat of Supply Chain Disruptions: Developing Contingency Plans for Cell Processing Labs
Wednesday, May 31, 2023 08:00 AM - 09:00 AM
Room 242B
Bioprocessing & Biomanufacturing
Roundtable
How can we establish backup critical materials and supplies by referencing lessons learned from COVID-19?
Moderator
Wanxing Cui, MD, PhD, Director, Cell Therapy Manufacturing Facility, MedStar Georgetown University, USA
Panelists
Cheryl Cox, MT(ASCP), CSSMBB, CABP(H), Director Operations Cell Therapy, Moffitt Cancer Center and Research Institute, USA
Emily Hopewell, PhD, Assistant Professor of Clinical Medical and Molecular Genetics,
Indiana University, USA
Ronit Slotky, PhD, MSc, Hackensack University Medical Center, USA
Jesse HT Ni, PhD, Vice President, BioLegend, A Perkin Elmer Company, USA
Session Description
Cell Processing Labs (CPL) play a vital role in autologous or allogeneic hematopoietic stem cell transplant programs. For routine lab operations, a resilient supply chain is required to ensure patient safety. However, the COVID-19 pandemic disrupted manufacturing and logistics operations worldwide and has profoundly affected CPL's supply chain. Discontinuation and severe backorders of supply are common supply chain issues for CPLs. For example, many CPLs have experienced short- and long-term backorders with Cryobags, safety needles, Cryovials, Spike adaptors, conical tubes, DMSO, Human serum albumin, and Plasmalyte.
Some of these items have even been discontinued by the manufacturer due to the broken supply chain. Unfortunately, these supply chain issues have not been solved thoroughly. For instance, CPLs prepare disaster plans, which include a backup facility, backup equipment, and backup personnel. However, these disaster plans lack adequate backup critical materials and supply to deal with the supply chain issues exacerbated by the pandemic. Thus, CPLs must identify supply chain issues and establish backup materials and supplies by process validation. In this session, the following topics will be discussed.
Learning Objectives
Moderator
Wanxing Cui, MD, PhD, Director, Cell Therapy Manufacturing Facility, MedStar Georgetown University, USA
Panelists
Cheryl Cox, MT(ASCP), CSSMBB, CABP(H), Director Operations Cell Therapy, Moffitt Cancer Center and Research Institute, USA
Emily Hopewell, PhD, Assistant Professor of Clinical Medical and Molecular Genetics,
Indiana University, USA
Ronit Slotky, PhD, MSc, Hackensack University Medical Center, USA
Jesse HT Ni, PhD, Vice President, BioLegend, A Perkin Elmer Company, USA
Session Description
Cell Processing Labs (CPL) play a vital role in autologous or allogeneic hematopoietic stem cell transplant programs. For routine lab operations, a resilient supply chain is required to ensure patient safety. However, the COVID-19 pandemic disrupted manufacturing and logistics operations worldwide and has profoundly affected CPL's supply chain. Discontinuation and severe backorders of supply are common supply chain issues for CPLs. For example, many CPLs have experienced short- and long-term backorders with Cryobags, safety needles, Cryovials, Spike adaptors, conical tubes, DMSO, Human serum albumin, and Plasmalyte.
Some of these items have even been discontinued by the manufacturer due to the broken supply chain. Unfortunately, these supply chain issues have not been solved thoroughly. For instance, CPLs prepare disaster plans, which include a backup facility, backup equipment, and backup personnel. However, these disaster plans lack adequate backup critical materials and supply to deal with the supply chain issues exacerbated by the pandemic. Thus, CPLs must identify supply chain issues and establish backup materials and supplies by process validation. In this session, the following topics will be discussed.
Learning Objectives
- What are the current supply chain challenges and issues in CPLs, and how can they be addressed?
- How can CPLs evaluate and manage their vendor network for critical materials and supplies?
- What strategies and best practices can CPLs adopt to optimize their supply chain management and improve overall resilience?
SPONSORED BY:
Wanxing Cui MD, PhD
Director, Cell Therapy Manufacturing Facility
MedStar Georgetown University
Moderator
Director, Cell Therapy Manufacturing Facility
MedStar Georgetown University
Moderator
Cheryl Cox MT(ASCP), CSSMBB, CABP(H)
Director Operations Cell Therapy
Moffitt Cancer Center and Research Institute
Panelists
Director Operations Cell Therapy
Moffitt Cancer Center and Research Institute
Panelists
Emily Hopewell PhD
Assistant Professor of Clinical Medical and Molecular Genetics, Director, Cell and Gene Therapy Manufacturing Chief Operations Officer, Brown Center for Immunotherapy
Indiana University
Panelists
Assistant Professor of Clinical Medical and Molecular Genetics, Director, Cell and Gene Therapy Manufacturing Chief Operations Officer, Brown Center for Immunotherapy
Indiana University
Panelists
