The need for a standardized audit approach

The rapid increase of emerging cell and gene therapies is putting stress on the infrastructure that supports the collection and processing of cellular starting material. Industry standardization can help ease this strain.

While there are many opportunities for standardization in cell collection and processing, one that could have an immediate impact is a quality system audit (QSA) program designed to assess collection centers and cell therapy labs for compliance to 21 CFR Part 1271 Good Tissue Practice (GTP), 21 CFR Part 211 Good Manufacturing Practice (GMP) and other quality-related requirements. The audit results are then licensed for use by the cell and gene therapy companies.

For therapies in development or commercially approved, each cell and gene therapy company conducts its own QSA of every collection center and cell therapy lab site that will collect and process cells. This requires significant investment by cell and gene therapy companies to implement an audit process, that includes the use of auditors familiar with the collection center practices, execute on time audit reports and address and oversee implementation of actions to address audit findings.

“Audits are absolutely necessary to ensure sites meet regulatory requirements, which are critical to the safe delivery of high-quality therapies. However, the differences between QSAs for each cell and gene therapy company are minimal and the frequency of audits is increasing,” said Amy Hines, R.N., B.S.N., director of Collection Network Management for Be The Match BioTherapies^®.

In September 2018, Be The Match BioTherapies conducted a survey of apheresis and marrow collection center staff in the National Marrow Donor Program^®/Be The Match^® Network. Forty percent of respondents said their center undergoes four or more audits/inspections annually, with 11 percent experiencing seven or more annually.

“In some cases, QSAs by cell and gene therapy companies are occurring almost back to back when corrective actions noted in the first audit are still being addressed and implemented. This leads to overlapping findings, sometimes with conflicting resolution requests by companies. It’s becoming difficult for centers to manage and an inefficient use of time for staff,” Hines said.

In addition to the frequency of requested audits, each audit is time consuming for therapy development companies, apheresis and cell therapy lab staff. More than 60 percent of survey respondents said their center devotes 31 or more hours on audit activities (i.e., pre-audit, during the audit and post-audit), with 31 percent spending 71 or more hours on these activities.

As the amount of time dedicated to audit activities increases, staff must spend less time providing patient care or on quality-related activities.

“If cell and gene therapy companies were to license the audit results from the QSA program, it could significantly decrease the amount of time centers spend on audit activities, while still ensuring the centers are meeting GTP and GMP regulatory requirements.,” said Ann Kemp, M.T. (A.S.C.P.), C.Q.A., R.A.C., who is the senior manager of Regulatory Compliance for Be The Match BioTherapies and leads the organization’s QSA Program.

With a QSA program, experienced auditors from the QSA organization audit each apheresis center and cell therapy lab one time on an established timeframe, such as every two years, and work with the center and lab to address any audit findings. Cell and gene therapy companies can license the audit results from the QSA organization, alleviating the necessity for multiple companies to conduct individual, yet similar audits.

“In order to keep pace with the industry and ensure high-quality therapies are delivered to patients, standardization in areas such as quality system audits is critical,” Hines said. “Coming together and working to alleviate the strain on the infrastructure through efforts like a QSA program will benefit cell and gene therapy companies, collection centers, cell therapy labs and, ultimately, our patients.”