Be The Match BioTherapies 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.”