Ensuring cell collection centers and cell therapy labs are meeting FDA regulatory requirements and providing high-quality starting material for your cell or gene therapy is critical to your therapy’s success. As the industry continues to rapidly advance, it is becoming more critical to integrate process efficiencies wherever possible.
There is a solution: using an established Quality System Audit Program (QSAP). Here are three ways QSAP can benefit your cell and gene therapy company.
For therapies in development or commercially approved, each cell and gene therapy company typically conducts its own quality system audit of each collection center and cell therapy lab that will collect and process cells.
This requires cell and gene therapy companies to implement an ongoing audit process, which includes the use of auditors with specialized knowledge of collection processes, execution of audit reports, and addressing and overseeing implementation of actions to address audit findings.
Many collection sites and cell therapy labs are receiving audit requests from multiple cell and gene therapy companies, which strains the essential collection infrastructure. When quality requirements differ minimally, if at all, between each cell and gene therapy, multiple audits lead to an inefficient use of time for collection staff members and takes them away from providing patient care.
The QSAP offered by Be The Match BioTherapies®, provides a standardized and more efficient solution for both collection staff and cell and gene therapy companies.
As part of the QSAP, experienced auditors audit each apheresis center and cell therapy lab for compliance with FDA 21 CFR Part 1271 GTP and 21 CFR Part 211 GMP once every two years (or an alternate established timeframe) and work with the center and cell therapy lab to address audit findings. Cell and gene therapy companies are then able to license the audit results from Be The Match BioTherapies, alleviating the necessity for each company to implement its own audit process. Further, multiple companies no longer need to visit the same collection centers and cell therapy labs to conduct individual, yet similar, audits.
Building the infrastructure to hire and train specialized auditors to conduct audits at each site is both time consuming and costly. The QSAP reduces those costs.
According to Chris McClain, vice president of New Business Development and Sales at Be The Match BioTherapies, the cost for a cell and gene therapy company to complete an audit of one collection center and cell therapy lab for compliance to GTP and GMP can range from $5,000 to $7,000. That doesn’t include the cost of hiring and training auditors.
Through Be The Match BioTherapies’ QSAP, for example, cell and gene therapy companies can purchase the audit results for an approximate $3,500 license fee, with an option to renew every two years – approximately half the price therapy developers would normally pay.
Activate cell collection centers and cell therapy labs sooner
Licensing audit results through the QSAP eliminates the need for duplicative quality system audits, and allows cell and gene therapy companies to more efficiently move centers and labs from qualification to actively collecting and processing starting material.
Typically, sites receive a four- to six-week notice that an audit will occur, the on-site audit itself takes one to two days, and corrective actions from findings are completed within a month post-audit.
Instead of taking weeks to months of time required to ensure quality compliance of a collection site, cell and gene therapy developers can license the audit results through the QSAP and get collection centers and cell therapy labs activated sooner.
Get additional information on the Be The Match BioTherapies Quality System Audit Program>