New program to provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks while minimizing quality system audit burden on centers
MINNEAPOLIS, Nov. 8, 2018 – Be The Match BioTherapies, an organization offering integrated platforms and software to manage the collection and delivery of cellular therapies, today announced the launch of its Quality System Audit Program (QSAP). The QSAP is a standardized auditing program designed to maximize process efficiencies for companies developing cell and gene therapies and for the collection networks that support these therapeutic programs.
Be The Match BioTherapies developed the QSAP as part of its ongoing efforts to lead and assist in the development of industry-wide standards that ensure efficiency throughout the cell therapy supply chain. Audits are conducted by experienced American Society of Quality (ASQ) certified auditors to evaluate collection center compliance with FDA Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) regulations. Licensing the audit results will streamline access to life-saving therapies by minimizing the time, cost and resources spent by both cell and gene therapy developers and apheresis centers on GMP and GTP audits.
“Our ultimate goal is to help cell and gene therapy companies more efficiently bring their therapies to patients,” said Ann Kemp, senior manager, Regulatory Compliance, Be The Match BioTherapies. “At Be The Match BioTherapies, we are committed to identifying areas in the cell and gene therapy ecosystem where standardization can benefit the industry and, most importantly, patients. Performing cell collection center quality system audits is one important area where our organization can add value.”
In September 2018, Be The Match BioTherapies conducted a nationwide survey of apheresis and cell collection centers contracted through its parent organization, the National Marrow Donor Program®/Be The Match®, to obtain insight into the challenges they’re facing due to the increased number of cell and gene therapies in clinical trials and nearing commercialization. The respondents cited challenges associated with implementing an increasing number of company-specific cell collection protocols as the biggest challenge related to facilitating cell and gene therapies.
“Through the QSAP, Be The Match BioTherapies can serve as an impartial intermediary between commercial cell and gene therapy developers and cell collection centers,” said Chris McClain, vice president, New Business Development and Sales, Be The Match BioTherapies. “Our goal is to accelerate access to new life-saving cell and gene therapies while ensuring that the needs of both industry and collection professionals are met.”
For more information about Be The Match BioTherapies’ Quality System Audit Program, please visit BeTheMatchBioTherapies.com/QSAP
About Be The Match BioTherapies
Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program/Be The Match, and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance cell and gene therapies in any stage of development.
Be The Match BioTherapies is dedicated to providing high-quality cellular starting material consented for research, clinical and commercial use, developing and managing expansive cell collection networks, and navigating cell therapy regulatory compliance. Using proven infrastructure to successfully manage autologous and allogeneic cell therapy supply chains, including MatchSource® Supply Chain Software, personalized case managers and logistics experts, the organization has a history of compliance managing the chain of identity. The collaboration with CIBMTR extends services to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.
Onboard cell collection facilities faster by obtaining our audit results measuring compliance with Good Tissue Practice (GTP), Good Manufacturing Practice (GMP) and other applicable quality measures.