FACT participates in several working groups of the Standards Coordinating Body (SCB), including the Cell Collection Standards for Cell and Gene Therapies group. The SCB website introduces this group as follows: “Because other advanced fields with similar biological products (e.g., bone marrow and apheresis) have established collection best practices, the regenerative medicine community is eager to leverage those practices to create an international collection process standard that will help ensure the consistency of the critical quality attributes of cells collected for regenerative medicine products.”
With interest and participation from industry and the United States Food and Drug Administration (FDA), the efforts of this group may impact FACT-accredited Apheresis Collection Facilities and we strongly encourage participation of apheresis professionals given their direct experience and expertise in cell collection.
Through the work of this group, SCB has successfully obtained agreement from the Parenteral Drug Association (PDA) to draft standards on cell collection. Although industry is the intended audience for these standards, requirements may be promulgated through the requirements that clinical trial sponsors and commercial manufacturers expect of apheresis collection sites in their networks.
The PDA is recruiting volunteers to draft the requirements, currently referred to as “Apheresis Collection for Cell and Gene Therapy Products,” until July 16, 2021. “The goal is to create a standard document outlining recommendations for product manufacturer/sponsor requirements for apheresis cell collection. It will also create a standardized template for the leukapheresis manuals/SOPs written by product manufacturers/sponsors for the apheresis centers. This combined effort will work to reduce the burden upon the collection centers and in doing so, reduce errors.”
FACT encourages participation from accredited Apheresis Collection Facilities. According to the PDA, volunteers must have some subject matter expertise, and be willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at email@example.com.
Apply to the PDA technical team for this standard by July 16, 2021!
To Our Colleagues in Industry:
The SCB is asking industry groups and manufacturers to share their apheresis collection requirements and guidance to help with the creation of the new Parenteral Drug Association (PDA) standard effort, PDA 08-202x: Apheresis Collection for Cell and Gene Therapy Products.
For this effort to be successful, the PDA working group will need a clear view of what industry groups and manufacturers currently require, so that it can fit the standard as close to common industry practices as possible. To gain that insight, please fill out this short survey. The data collected will only be viewed/used in aggregate and will not be used outside of the standards effort. Please fill out this survey at your earliest convenience.