The NIIMBL Dockets Response Committee responds to key regulatory topics in biopharmaceutical manufacturing.
Submission Date: March 27, 2024
NIIMBL, on behalf of our community, recognizes the individual efforts involved in generating the Draft Guidance and appreciate the Agency’s efforts to clarify expectations and expand the scope from Potency Tests (2011) to Potency Assurance Strategy in a new and continuously evolving product area. The feedback provided in this response to the docket focuses on assuring the utility of the document for advancing risk-based, patient-centered biopharmaceutical manufacturing through clarity of expectations, consistency with existing guidance and regulation, and technical excellence.
Submission Date: February 13, 2024
NIIMBL submitted comments to Docket Number FDA-2023-D-4974, Advanced Manufacturing Technologies Designation Program: Guidance for Industry (Draft). We appreciate the Agency continuing to support the need for modernization of manufacturing technologies, especially for biologics and emerging modalities. We recommend additional clarification around the benefits of AMT designation to the industry, a separate guidance document for biologics, and additional clarity around the lifecycle of an AMT technology, including communication from the FDA around which technologies are AMTs. Incorporating modernized manufacturing technologies in biopharma processes is critical to improving quality and supply of life saving medicines and we look forward to continued conversations about advanced manufacturing technologies.
Submission Date: December 13, 2023
NIIMBL, on behalf of our community, recognizes the individual efforts involved in developing this Program and we appreciate the opportunity to comment. We acknowledge that assessment of quality culture as an additional consideration in a quality systems management approach is important and impactful. There is value in promoting quality culture in the regulated industry and identifying areas that require attention.
Submission Date: November 20, 2023
NIIMBL appreciates this opportunity to comment on the thoughtful and important questions posed in this RFI. We understand the preparation of CGTs as an exercise in manufacturing rather than practice of medicine, that CGTs will be regulated under existing statutes of the FD&C and Public Health Service Acts and associated Guidance to Industry, and fully support these positions as matters of policy. While the questions in this RFI are directed at the unique challenges in developing CGTs, we feel that many of the questions apply more broadly to the challenges of developing commercial biologics in general and are addressed in existing Guidance. All biologics are developed on aggressive timelines to meet patient needs, must manage patient populations of different sizes and demographics, and must manage the interconnected complexities of translational science, commercialization, and basic research. We would however advocate, to the extent possible, for a harmonization of review, inspection practices, regulatory considerations, and exception within the FDA. Divergence of practices leads to uncertainty surrounding CMC expectations for regulatory compliance. Rather than identify more and more exceptions and subclasses of consideration, we suggest that the Agency would be better served to affirm that established requirements for INDs, BLAs, and phase-appropriate application of the GMPs are fully relevant to CGTs and to work to align expectations for submission, review, and inspection across different Centers and Offices within the Agency.
Submission Date: July 25, 2023
NIIMBL, on behalf of our community, recognizes the individual efforts involved in generating the Draft Guidance and we appreciate the opportunity to comment. This Draft Guidance does not represent a significant departure of philosophy or practice from previous FDA guidance and it is reassuring that CBER is committed to regulating cell and gene therapy (CGT) products within the current FDA and ICH regulatory framework. The feedback provided in this response to the docket focuses on assuring the utility of the document for advancing risk-based, patient-centered biopharmaceutical manufacturing through clarity of expectation, consistency with existing guidance and regulation, and technical excellence.
Submission Date: May 4, 2023
NIIMBL’s mission is to accelerate biopharmaceutical manufacturing innovation and we aim to reduce barriers to adoption of advanced manufacturing technologies, therefore our comments are specific to the manufacture of biologics that would be marketed under a Biologics License Application. We consulted with subject matter experts from within our membership and have endeavored to make our comments brief and specific. They do not represent the full scope of comment and concern raised by NIIMBL members but are fully consistent with the themes and arcs of member feedback.
Submission Date: May 4, 2023
Our comments to the docket are focused on the needs of the biopharmaceutical industry, the primary focus of NIIMBL’s expertise. The biopharmaceutical industry provides advanced health care solutions for patients, provides high value, low volume, low emission manufacturing opportunities. The Coordinated Framework for the Regulation of Biotechnology as currently established is highly effective in the vast majority of applications. It is important to address exceptions, but these exceptions should not drive gross revisionism. In our responses to specific questions, we highlight some areas where additional clarity would be welcome, and aim to provide suggestions that improve the experience of our stakeholders, particularly around consistency within and between agencies.
Submission Date: December 8, 2021
NIIMBL collected and analyzed anonymized feedback on this Draft Guidance from its membership and then led discussions based on this feedback at NIIMBL Regulatory Considerations Committee meetings. All responses acknowledged the magnitude of the task and were appreciative of the individual efforts involved in generating the Draft Guidance. The feedback provided in this response to the docket focusses on assuring the utility of the document for advancing risk-based, patient-centered biopharmaceutical manufacturing through clarity of expectation, consistency with existing guidance and regulation, and technical excellence in manufacturing controls.
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