FDA, Genentech, Minaris Panelists Detail Raw Material Risk Strategies for Advanced Therapies

At the 2026 PDA/FDA Joint Regulatory Conference, a panel on "Navigating Complexities of Raw Materials in the Manufacturing of Advanced Modalities" addressed how sponsors and manufacturers source, qualify, and manage raw materials for cell and gene therapies. Marc Glogovsky, MS, business unit manager of microbiology at ValSource, moderated a discussion with Athenesia Faggins, PhD, director of analytical sciences at Minaris Advanced Therapies; Lori Dingledine, director of QC microbiological control and GTIC operations at Genentech; and Gauri Lamture, PhD, a gene therapy reviewer at FDA's Center for Biologics Evaluation and Research.¹

How should companies balance speed and quality when transitioning raw materials from research-grade to GMP?

Panelists said the shift from research-use-only (RUO) to good manufacturing practice (GMP)-grade materials should happen as early as possible and be built into formal procedures rather than left ad hoc. Dr Faggins said that transition should be a gated milestone, such as moving from pilot to engineering runs or from phase 1 to phase 2, with a defined strategy, additional testing, or a closer working relationship with the supplier, for periods when GMP material is not yet available. Dr Lamture and Dingledine agreed the tension between speed and quality ultimately falls to the quality and regulatory teams, who must defend material decisions to regulators, even when manufacturing pushes for pace.¹

How do companies manage lot-to-lot variability in critical raw materials?

Dr Faggins emphasized that testing strategy should scale with a material's risk and behavior. Fetal bovine serum, for example, must be functionally tested on cells for every lot because performance cannot be predicted from specifications alone, while for materials such as cytokines, a company might test several lots for biological activity at supplier qualification and then retest only annually or every few years once consistency is established. Dingledine added that the same logic extends to reagents used in quality-control laboratory methods, not just production raw materials.¹

Who is responsible for raw material supplier oversight—the sponsor or the CDMO?

Dr Faggins said sponsors retain ultimate responsibility because they submit the regulatory filing, so material risk control must be a collaboration between the sponsor and the contract development and manufacturing organization (CDMO), with the CDMO's policies accommodating a range of sponsor expectations and the sponsor given transparency into supplier quality. Dingledine noted that bringing sponsor and CDMO subject-matter experts together in person builds the shared understanding that makes that oversight work. On handling a single-source supplier reluctant to permit quality audits, Dr Faggins recommended first assessing how significant the withheld information is, then negotiating alternative terms with the supplier if the material has no substitute, reserving a switch to another material for when risk cannot otherwise be resolved.¹

How should raw material information be organized in a BLA CMC section, and how should companies justify dual sourcing?

Dr Lamture explained that FDA reviewers want raw material information presented in tabular format within the chemistry, manufacturing, and controls (CMC) section of a biologics license application (BLA), covering the material's identity, source and vendor, where it is used in the process, applicable specifications and tests, and, for animal- or human-derived materials, adventitious-agent testing and sourcing from approved geographies, including transmissible spongiform encephalopathy/bovine spongiform encephalopathy testing. On justifying dual sourcing and safety stock to management, Dr Faggins and Dingledine said the strongest argument is patient impact, stating that a delayed or canceled production run delays treatment and clinical data. In addition, the cost of a canceled run typically exceeds the cost of maintaining backup material.¹

What did panelists say about releasing materials at risk, and where should newcomers start?

Asked about using raw materials in production before their own testing is complete, known as releasing at risk, Dingledine and Dr Faggins explained the practice is common in advanced therapy manufacturing but should be tightly controlled. For instance, releases must be documented and reserved for cases where delaying or canceling a patient-specific run is not an option. Releases must also be verified by a subject-matter expert confirming the material is on test and specifications are in place.

For newcomers to raw material qualification, the panelists pointed to an industry points-to-consider guideline spanning cell and gene therapy, the United States Pharmacopeia general chapter on ancillary materials for cell, gene, and tissue-engineered products,² and FDA draft guidance on human- and animal-derived materials in cell and gene therapy manufacturing.³

The PDA/FDA Joint Regulatory Conference 2026 is taking place September 14-16, 2026, in Washington, DC.

Explore more conference coverage here.

References

1. Parenteral Drug Association. PDA/FDA Joint Regulatory Conference 2026. Accessed September 14-16, 2026. https://www.pda.org/global-event-calendar/event-detail/pda-fda-joint-regulatory-conference-2026#agenda
2. USP. General Chapter <1043> Ancillary materials for cell, gene, and tissue-engineered products. USP-NF. Accessed September 17, 2026. https://doi.usp.org/USPNF/USPNF_M620_02_01.html
3. FDA. Draft guidance for industry, considerations for the use of human- and animal-derived materials and components in the manufacture of cell and gene therapy and tissue-engineered medical products (CBER, April 2024). Accessed September 17, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue