PDA-Led Project: Cryopreservation of Cells

TYPE: STANDARDS ADVANCEMENT PROJECT

PARTNERS: The Parenteral Drug Association (PDA) and The SCB Cell Therapy Sector Working Group

DESCRIPTION:

Cell therapy products are made of living cells and typically have short shelf lives—often only 1–3 days. Cryopreservation of cells can extend product life for sterility testing; transport between donation, manufacturing, and administration facilities; or temporary storage.

Though cryopreservation is often crucial to successfully administer a cell therapy product, the freezing process can alter cells, affecting product quality and potency. The cryopreservation process has a large number of variables, including but not limited to media choice, freezing rates, and thaw temperatures. Standards will help to establish consistent and minimally damaging cryopreservation practices with reproducible results.

SCB is supporting a PDA-led effort to develop a consensus-based standard that will provide a common framework for selecting cryopreservation methods.

Progress:

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Note: Projected dates are estimates only. Development of a standard depends on SDO timelines, which can vary.

Identified Standards Need: PDA initiated the project in response to stakeholder requests for guidance on establishing evidence-based best practices for cryopreservation methods for cells for therapeutic use. PDA determined that a standard would best address this need and reached out to SCB for expert input and support.

Assembled a Working Group: PDA has developed a diverse task force—of which SCB is a part—to develop an initial draft standard. SCB has coordinated a larger expert working group with ongoing project calls to provide targeted input to the task force and increase engagement and awareness of this standard. The working group is currently outlining the various areas that will need to be addressed in this standard to complete the initial standard draft.

GET ENGAGED:

To join the SCB working group or learn more about this initiative, please contact SCB.