After approximately four years of working on the guide, I’m happy to announce that our efforts and dedication have paid off. The PDA has published the draft of BSR/PDA Standard 08-202x: Guidance for Manufacturers — Apheresis Collections for Cell & Gene Therapy Products, opening it for public review and comment.
This is a pivotal moment for our community. Cell and gene therapy manufacturing depends on consistent, high-quality starting material — and apheresis collection is one of the most critical “first links” in that chain. Poor collection practices, inconsistent donor processing, or unclear expectations can ripple downstream, affecting viability, purity, potency, and regulatory acceptability.
Why This Standard Matters
- Harmonization Across Collection Sites & Sponsors The draft aims to align expectations between manufacturers, contract apheresis sites, and regulators — reducing ambiguity and misalignment in the donor-to-manufacturing handoff.
- Risk Mitigation & Quality by Design Defining key parameters (e.g., start- and end-of-collection criteria) helps sponsors more confidently design control strategies and risk assessments. The standard links closely with the Standards Coordinating Body’s initiative to define cell collection workflows.
- Regulatory Alignment & Expectation Setting Having this standard under PDA (an ANSI-accredited SDO) brings the potential for regulatory weight and clarity. PDA’s open, consensus process ensures that your voice in the review matters.
- Timely Call for Input — Deadline Approaching The public comment window closes Dec 1, 2025. If your organization handles apheresis collections, sponsors cell therapies, or audits collection sites, your feedback is essential.
Key Topics
Various topics include:
- Donor eligibility assessments
- Collection parameters
- Handling and transport of collected material
- Quality attributes (viability, cell subset distribution, sterility)
- Documentation, chain of identity / custody
- Apheresis site qualification and oversight
- Change control and comparability expectations
- Training and competency requirements
You’ll want to review the draft carefully in these areas and see how they match your internal practices.
What You Can Do
- Download the Draft & Comment Sheet — PDA provides a free draft and commenting form via its standards page.
- Assemble a Cross-Functional Review Team — Include your process development, apheresis operations, quality, regulatory, and partner/CRO input.
- Offer Constructive Feedback — Focus on feasibility, clarity, potential gaps, and alignment with current best practices.
- Submit Formal Comments by Dec 1, 2025 — Late submissions are often given less weight.
- Leverage Your Network — Encourage industry colleagues and apheresis centers to review and comment — standards gain strength with broad input.
Broader Implications for the Industry
As the cell therapy arena grows, standards like this are no longer optional — they become anchors of regulatory expectation. Adopting and aligning to consensus standards early can help reduce delays, avoid audit surprises, and build confidence in your entire donor-to-product chain.
If you’d like help interpreting the draft, preparing comments, or benchmarking your apheresis processes against the draft language, let’s connect. I’d be glad to help you turn this opportunity into a competitive advantage.
Learn more & get the draft: https://www.pda.org/scientific-and-regulatory-affairs/standards/pda-bsr-standard-08-202x Default
Remember: Public comment period ends December 1, 2025.