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 many 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 supported a PDA-led effort to develop a consensus-based standard that provides a common framework for selecting cryopreservation methods.

Progress:

(learn more about the standards advancement process)

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

Supporting Standard Drafting: PDA developed a diverse task force—of which SCB is a part—to develop an initial draft standard. SCB 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.

Standard Published: The standard was published in January 2022 as PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing

GET ENGAGED:

To learn more about this initiative, please contact SCB.