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The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
On Nov. 8, 2018, Be The Match BioTherapies, a company offering integrated platforms and software to manage the collection and delivery of cellular therapies, announced the launch of its quality system audit program (QSAP), 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.
QSAP is meant to 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 these 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, in a company press release. “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 of dealing with an increased number of cell and gene therapies in clinical trials and nearing commercialization. The implementation of an increasing number of company-specific cell collection protocols was cited 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, in the press release. “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.”
Source: Be The Match BioTherapies