Stakeholders urge greater collaboration to promote innovative manufacturing

A proposed US Food and Drug Administration (FDA) draft strategy document on innovative manufacturing should stress greater collaboration with other regulators to promote the use of advanced technologies, according to comments posted by biopharmaceutical stakeholders who added that the plan lacks detail on leveraging artificial intelligence and machine learning (AI/ML) in innovative manufacturing.

In September, FDA invited comments on a draft strategy document aimed at promoting the adoption of innovative manufacturing technologies for drugs and biologics (RELATED: FDA seeks input on its innovative manufacturing technology strategy, Regulatory Focus 12 September 2024).

The plan responds to a mandate in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals for Fiscal Years 2023-2027 (PDUFA VII) to advance the implementation of innovative manufacturing. The document also details new milestones and procedures for the agency’s Emerging Technology Team (ETT) and Advanced Technology Team (CATT) as well as plans for issuing a finalized guidance on its Advanced Manufacturing Technologies Designation Program (AMTDP).

The agency received five comments on the plan, all from pharmaceutical groups and associations.

More international collaboration

Commenters suggested that the FDA collaborate more with its regulatory counterparts to advance innovative manufacturing.

The Pharmaceutical Research and Manufacturers of America (PhRMA) encouraged the agency to “identify opportunities to encourage appropriate international harmonization of regulatory standards for advanced manufacturing in various multi-stakeholder forums.”

PhRMA suggested FDA could share more insight on its experiences with the Center for Drug Evaluation and Research (CDER) Emerging Technology Program (ETP) and the Center for Biologics Evaluation and Research (CBER) Advanced Technology Teams (CATT), on the adoption of advanced manufacturing technologies.

To further support these harmonization efforts, PhRMA suggested FDA advise sponsors on whether technology would be a suitable candidate to receive Parallel Scientific Advice from the European Medicines Agency Quality Innovation Group (QIG).

The Biotechnology Industry Organization (BIO) also suggested that the strategy document should stress more collaborative activities. The group wrote the draft document limits harmonization activities to existing tools such as parallel scientific advice with the EMA QIG.

“We recommend extending these activities to include collaboration on guideline development to achieve international harmonization. Activities could include more communication of past experiences with the review and approval of advanced manufacturing technologies to facilitate education of other health authorities with these technologies, to help gain acceptance. We also suggest the agency make publicly available information related to meetings with international health authorities, i.e. meeting reports,” the BIO comment said.

The Alliance for Regenerative Medicines (ARM) also urged FDA to prioritize international collaboration and to take a leadership role in collaborating with the International Council for Harmonisation (ICH). These activities could include developing training materials on ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products and ICH Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, which includes viral safety considerations for continuous manufacturing of biological products.

Plan should address AI/ML

Both PhRMa and BIO said the strategic plan lacks detail on how AI/ML could be used to support innovative manufacturing.

PhRMA states that in the FDA Framework for Regulatory Advanced Manufacturing (FRAME), the agency identified four technologies as having transformative potential for manufacturing. Of the four, the draft strategy mentioned only distributed manufacturing. “We encourage the agency to use this strategy to set goals for all four technologies in the framework,” the group said.

BIO concurred. “The document mentions only Decentralized [sic] Manufacturing, while there are currently four FRAME priority areas identified. Notably absent is the topic of AI and ML applications in manufacturing. We recommend including all FRAME prioritized technologies including topic-specific goals for each area.”

More detail on ATM designation

BIO further recommends that the plan includes additional details on how the Advanced Manufacturing Technology (AMT) designation program would advance the field of innovative manufacturing. It should list the benefits of participating in the program and provide more clarity on the differences between the ETP/CATT and AMT program business processes.

ARM concurred with this assessment and said that the plans should include a “more detailed vision” of how AMT designation can play a role in “de-risking” manufacturing innovation.

In other areas, the American Society of Gene & Cell Therapy (ASGCT) said the agency should better distinguish between the CATT program and the AMT program.

The group wrote that the AMT designation program “was intended to serve a separate purpose” than the CATT program. “We are concerned that the Agency has suggested that, in most cases, CATT interaction should happen prior to AMT, and AMT eligibility should align with CATT eligibility….We respectfully request greater clarity on the attributes of technologies that are appropriate for the CATT and AMT programs and request the removal of the tie between the programs’ entry criteria as referenced in draft guidance and inferred in the strategy document.”

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Stakeholders urge greater collaboration to promote innovative manufacturing

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