Cytotherapy Article Illustrates Increasing Variations in MNC Collection Requirements for Commercial and Investigational Products
Cytotherapy published Handling the different requirements for commercial and investigational MNC collections by apheresis (Bobr, Roberts, et al, 2024), an article that illustrates in a compelling way that MNC collection requirements are increasing in variety.
The authors analyze MNC starting material collection requirements from all FDA-approved and some investigational CAR T cell products for which collection is performed at the University of Nebraska Medical Center. They identify discrepancies and suggest mitigation strategies.
The article includes the following illustration of the requirements for eight different products. This illustration clearly conveys the overwhelming differences that Collection Facilities must manage and presents the risks to compliance in a visibly astounding way.
The article provides example efforts of several stakeholders in the field to reduce and minimize variations, including working groups to harmonize manufacturer requirements and the development of quick-reference work aids for collection staff. Many people from FACT-accredited programs, including FACT inspectors and committee members, volunteer on multistakeholder groups in support of these efforts and we appreciate the valuable time and thought you contribute to this important issue.
Handling the different requirements for commercial and investigational MNC collections by apheresis. Bobr, A., Roberts, T., Koepsell, S., Williams, S.M., Schwartz, J. April 6 2024. Cytotherapy, Volume 26, Issue 8, 948 – 953. doi: 10.1016/j.jcyt.2024.04.001
