A practical guideline for implementing multi‑product resin re‑use in biopharmaceutical manufacturing

<jats:p>Chromatography resins remain one of the most significant cost, capacity, and supply‑chain constraints in downstream bioprocessing—particularly in multi‑product facilities and early‑stage manufacturing. Yet across the industry, proven approaches to safely re‑using resins across multiple products are still unevenly understood and applied. This publication brings together cross‑company experience and evidence‑based practices to address this challenge head‑on. Developed by members of the BioPhorum Drug Substance community, the guideline provides a structured, risk‑based framework for evaluating, implementing, and governing multi-product resin reuse (MRR) without compromising product quality, patient safety, or regulatory expectations. Inside the guideline, you’ll find: An overview of current industry practice and why single‑product resin use often leads to significant under‑utilization. Practical guidance on laboratory‑scale suitability assessments, including product degradation studies, cleaning strategy development, and carryover analysis. A clearly articulated risk‑based approach for implementing MRR in GMP environments, aligned with ICH Q9(R1). Insights from real industry case studies, including successful applications in non‑clinical and early‑phase clinical manufacturing. Considerations for regulatory engagement and dossier strategy when MRR is used for clinical or commercial supply. Rather than promoting a single solution, the guideline sets out the scientific, operational, and quality considerations needed to determine whether MRR is appropriate on a product‑by‑product basis—and how to implement it responsibly where it is.</jats:p>