Multistakeholder Group Develops Risk-Based Assessment Process for Qualifying Facilities Collecting Cellular Starting Material
The multistakeholder Deloitte NextGen Industry Working Group’s site certification workstream developed a risk-based assessment process for qualifying facilities collecting cellular starting material (CSM). This effort was a shining example of experts in the field developing a process that meets the needs and obligations of the many types of entities involved in the cellular therapy product supply chain.
An article published in December 2024 in Transplantation and Cellular Therapy proposes that manufacturers adopt this process, and the authors provide the associated tools and instructions for how to use them.
Adopting risk-based assessments such as this approach will be critical for cellular therapy programs to be able to offer the many cellular therapy products that are increasing in number and diversity to patients. Many facilities are reaching a critical point in which they will not be able to onboard additional products because of the duplicative and unfunded burdens associated with each individual manufacturer. By utilizing measures of quality already in existence, and evaluating the risks associated with a given product and a given facility, site qualification can be more streamlined for both industry and programs and make more products available to patients.
Risk-Based Qualification of Cellular Starting Material Collection Sites: Tools to Determine Scope of Manufacturer Audits and Reduce Duplicative Efforts. Holman, Peter et al. Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy, Volume 30, Issue 12, 1171 – 1177. Available at https://www.astctjournal.org/action/showCitFormats?doi=10.1016%2Fj.jtct.2024.09.006&pii=S2666-6367%2824%2900657-2.
