The Standards Coordinating Body (SCB) was formed as an answer to the Advancing Standards in Regenerative Medicine Act, and holds contracts with the Food and Drug Administration (FDA) to advise the agency on needed standards in regenerative medicine. It formally supports many standards development efforts in conjunction with other organizations. FACT is an engaged member organization and participates in SCB projects and provides regular feedback as requested by the SCB.
Did you know that the transplant and cord blood banking communities are critical to the SCB’s efforts?
Although “regenerative medicine” is a very broad term with connotations related to “new” or “novel” therapies, many of the SCB’s projects relate to issues in which FACT-accredited organizations have decades of experience. Accredited organizations are often the facilities that collect cellular starting material, perform contract manufacturing or supportive processing and cryopreservation procedures, or clinically support specialties not yet experienced in cell and gene therapies. Even those organizations that are not directly involved have had to evaluate, resolve, and manage solutions to the very challenges newer players in cell and gene therapies are struggling with now.
Please share your experiences and expertise with the Standards Coordinating Body!
Your input will assist the SCB with its mission, inform commercial manufacturers and other specialties on inherent differences in cell and gene therapies, and promote solutions that harmonize with existing Standards and regulations. The SCB’s outputs could directly impact your daily work and, more importantly, help expedite availability of therapies to patients sooner rather than later. Express your interest in participating in SCB projects to Dawn Henke, SCB Senior Technical Program Manager, at firstname.lastname@example.org.
The following are notable SCB initiatives that are likely of interest to many FACT-accredited organizations. There are many more that may be intriguing based on professional interests. For a full listing of projects and reports, visit the SCB’s website at https://www.standardscoordinatingbody.org.
- Cell Collection Standards for Cell Therapies: FACT, SCB, commercial manufacturers, and many other organizations have heard, loud and clear, that apheresis facilities are struggling with the increasing volume of effort required of variable collection and audit requirements. This project group is currently formulating surveys to distribute to industry and apheresis facilities to learn what needs could be reconciled and then standardized.
- Cryopreservation of Cells (PDA-led project): Many commercial manufacturers have sought best practices related to cryopreservation and have had to adjust those practices to fit the needs of their particular cellular therapy products. This project group is drafting a framework on which to establish cryopreservation procedures in the hope to standardize requirements when possible.
- Transportation Requirements of Cells for Therapeutic Use: Shipping and transportation have a direct and significant influence on chain of custody and chain of identify of cellular therapy products, and is of great interest to commercial manufacturers. This project group is working to identify gaps in current Standards. Due to the emphasis on shipping and transportation requirements in FACT Standards, efforts to remain harmonization with these existing Standards will prevent conflicting requirements.
- Community Perspectives: Needed Standards in Regenerative Medicine Report: This report, based on input from many stakeholders, outlines needed standards that could have the greatest benefit to the safety and quality of regenerative medicine products. The draft is currently available, and will be updated as needed based on comments the SCB received during its recent public comment period in May 2019.