The success of a cell therapy depends on the collection of high-quality starting material. But currently, a number of barriers are impacting the capacity of collection centers, which in turn, can create obstacles throughout the supply chain and delay delivery of cell therapies.
Cell and gene therapy developers are required by the FDA to ensure centers that collect starting material meet regulatory requirements. Auditing centers for compliance to FDA Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) regulations is critical to ensure compliant source material. With multiple cell and gene therapy companies using the same collection centers, the result is often multiple nearly-identical audits for the collection center. Each audit requires pre-, day-of and post-audit activities that take staff away from providing patient care.
In addition to the recurring audits for regulatory compliance, companies must also train collection center staff on company-specific requirements for starting material. For cell and gene therapy companies, building infrastructure to hire and train highly-specialized auditors to conduct audits at each site is both time consuming and costly.
As a partner to both collection centers and cell and gene therapy developers, Be The Match BioTherapies® is working with collection centers and industry leaders to devise a solution to eliminate inefficiencies in cell harvest, including minimizing the audit burden on collection centers. Our newly launched Quality System Audit Program (QSAP) offers a standardized and cost-effective solution. Through this program, our experienced and certified quality auditors audit apheresis centers and cell therapy labs for compliance with 21 CFR Part 1271 GTP and 21 CFR Part 211 GMP. Cell and gene therapy developers are then able to license the audit results, eliminating the need to invest in expensive infrastructure and training of auditors, and more efficiently onboard centers and labs to begin collection and processing of starting material.
According to Chris McClain, vice president of New Business Development and Sales at Be The Match BioTherapies, “It generally costs a cell or gene therapy company $5,000-7,000 to audit an apheresis site for compliance to GTP and GMP. We’re offering the exact same audit for a $3,500 license fee through Be The Match BioTherapies’ QSAP. Once the license is purchased, the company has the option to renew every two years. It’s a win-win situation for multiple players in the industry. Apheresis centers only have to be audited every two years, and cell and gene therapy developers get access to audit results for half the price they would normally pay.”
Standardizing the audit process also allows cell collection centers and cell therapy labs to reduce the number of resources spent on audit activities. Heather Steinmetz, M.P.H., quality assurance manager, Hematologic Malignancy/Stem Cell Transplant Program, UCLA Health said, “Be The Match BioTherapies is really in quite a unique position to assist centers and industry as we develop these new therapies. The idea that the audit could be conducted once, instead of repeatedly by multiple commercial cell and gene therapy developers is an innovative approach. This program will allow our staff to focus on patient care and quality cellular starting material harvest as opposed to preparing for and enduring audits throughout the year.”
Companies who license audit results through our Quality System Audit Program receive an on-site audit checklist with notes and supporting documentation reviewed, an audit report, an audit findings response form, an audit closure letter at a significantly lower price than an independently commissioned audit.