Here is the recap from the OSD. There is no recording but presentation and contact information for the speakers are included below.
Raw and Ancillary Material Quality Standards in Gene and Cell Therapy Products: Key Insights from Industry and Pharmacopeia Experts
In a recent open scientific discussion on raw and ancillary material quality standards in gene and cell therapy product development, industry and pharmacopeia experts shared valuable insights and best practices. The discussion highlighted several crucial aspects of ensuring material quality and regulatory compliance in this rapidly evolving field.
The importance in defining fit-for-purpose materials was a recurring theme. Experts emphasized the need for secondary level traceability as a minimum requirement from regulators. Building strong relationships with suppliers based on trust was noted as essential for maintaining quality standards.
Performance testing and risk-based approaches were discussed, with experts advocating for phase-appropriate strategies. The conversation touched on various materials, including plasmids, and their critical role in cell and gene therapy production. It was noted that some materials are more critical than others, with particular emphasis on the quality of plasmids. The discussion referenced USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products and USP <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies, highlighting the importance of adhering to established quality standards for these crucial components.
A key takeaway was the importance of thorough quality attribute assessment for incoming materials, particularly cells. Experts advised against relying solely on supplier information and stressed the need for independent verification of quality. This point was underscored as a primary cause of clinical holds for investigational new drug applications (INDs).
The discussion also covered viral safety and residual testing, especially in the absence of sterile filtration options for some products. Experts recommended a case-by-case risk assessment approach, considering factors such as material source, intended use, and potential contaminants.
Strategies to enhance compliance with regulatory standards in gene and cell therapy production were also addressed. Experts recommended:
1. Actively listening to industry developments
2. Attending conferences to stay updated on best practices
3. Allowing regular audits (1-2 per month) to ensure ongoing compliance
4. Familiarizing oneself with key regulations such as 21 CFR 210/21 CFR 211, which outline current good manufacturing practice for finished pharmaceuticals
Regulatory guidance documents are crucial resources for staying compliant including emerging guidance such as Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents (EP 2.6.41) in Pharmeuropa 36.2 and ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline.
The session concluded with a reminder of upcoming FDA draft guidance documents open for public comment through July 29, including considerations for using human and animal-derived materials in cellular and gene therapy products.
This discussion provided valuable insights for professionals in the gene and cell therapy field, emphasizing the critical nature of material quality standards in ensuring product safety and efficacy. If you have any questions for the speakers, their contact information is below:
Lynn Csontos, STEMCELL Technologies - [email protected]
Ben Clarke, US Pharmacopeia - [email protected]
Mo Heidaran, Cellx Inc Consulting - [email protected]
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 06-18-2024 08:53
From: Allison Radwick
Subject: OSD: Raw and Ancillary Material Quality Standards in Gene and Cell Therapy Products July 9 from noon to 1 pm EST
Please join us Tuesday July 9, 2024 from 12 noon – 1 pm EST for a virtual Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs), Excipients and Regulatory Sciences Communities on the following topic:
Raw and Ancillary Material Quality Standards in Gene and Cell Therapy Products
• What are the USP initiatives to support quality and consistency of emerging modalities?
• How can we enhance compliance, supplier management, good manufacturing practices, traceability, and viral safety?
• What are best practices for raw and ancillary material control and evaluation?
Discussion Leaders:
Ben Clarke (USP)
Lynn Csontos (STEMCELL Technologies)
Mo Heidaran (Cellx Inc Consulting)
Organized by:
Allison Radwick (USP)
Ami Patel (Boyds Consultants)
We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.
(Please remain on mute unless asking questions)
Where: https://meet.goto.com/505947717
You can also dial in using your phone.
United States: +1 (646) 749-3122
Access Code: 505-947-717
Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 505-947-717
Or dial directly: [email protected] or 67.217.95.2##505947717
Please feel free to share with colleagues who may be interested in this topic. Thank you!
The AAPS GCTPs, Excipients and Regulatory Sciences Communities Leadership Teams
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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