Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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40 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Quality Collaboration there was a need for further collaboration to achieve align- ment to ensure safe CSTD usage with biologics. The event facilitated an open discussion of the pros and cons of using CSTDs with biologics and development of a holistic perspective on product-agnostic and product-specific chal- lenges associated with CSTDs. Importantly, the data presented by IQ highlighted potential quality and patient impact of CSTD use and that a strong partnership between pharma companies and device manufacturers is crucial to ensure compatibility of CSTDs with biologics. The workshop positioned IQ as a leading industry voice on CSTDs, advanced technical relationships and discussions with key stakeholders, and resulted in discussions in other forums including the Association for the Advancement of Medical In- strumentation, the Product Quality Research Institute, and the American Association of Pharmaceutical Scientists. The WG authored a publication (8) and summarized results in an IQ webinar scheduled for March 18, 2021 to share the dis- cussion and learnings. Continued stakeholder discussions will further alignment on CSTD use with biologics and highlight IQ's role as a forum for enabling cross-stakeholder collaboration. Phase-appropriate specifications International Conference on Harmonization of Technical Re- quirements for Registration of Pharmaceuticals for Human Use (ICH) Q6B, Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products (9), does not address the use of science- and risk-based development approaches for establishment of specifi- cations. The lack of clear globally harmonized guidance for how to combine ICH Q6B and science and risk-based approaches per ICH Q8–Q11 (10–13) creates challenges for implemen- tation of fit for purpose first-in-human (FIH) and commercial specifications. The challenge for FIH specifications is the lack of product experience early in development and the need to utilize prior knowledge to inform on attribute impact. For commercial products, basing specifi- cations solely on characteristics outlined in ICH Q6B (primarily clinical experi- ence range) often results in inappropriate specification limits that adversely impact the shelf-life, results in rejection of lots with acceptable quality, and limits pa- tient-centric lifecycle improvement ef- forts such as new formulations, devices that enable home administration, and room temperature storage periods. The goal of the Phase-Appropriate Specifications WG is to facilitate the implementation and regulatory accep- tance of a science and risk-based patient centric approach for specification setting for biologics (Figure 3). The initial focus of the WG was the development of FIH platform specifications for monoclonal antibodies (mAbs) and antibody-drug conjugates (ADC). Subsequently, the WG turned its attention to identifying common industry strategies for applying a science- and risk- based approach to establishment of patient-centric commer- cial specifications for standard biotherapeutic products such as mAbs and ADCs. The WG used a combination of literature review, pre-compet- itive team discussions, and an IQ-supported blinded survey of member companies to gather information on specification-set- ting current best practices. The survey allowed for a compre- hensive, anonymous assessment of the methods and acceptance criteria typically used by member companies for FIH biologic products. For the commercial specification effort, team dis- cussions were used to identify common best practices for de- velopment of patient-centric specifications. Case studies were used to highlight how individual IQ member companies used process and product understanding to justify specifications and specification ranges. In 2019, the WG published a white paper on the FIH specifi- cation effort, which includes results of the blinded survey and a specification platform to support mAb/ADC FIH products (6). The platform specifications and their justifications provide a framework of attributes, methods, and acceptance criteria that have been found to be broadly applicable to FIH mAbs and ADCs. The platform specifications provide a guide for industry and regulators that balances the depth of development efforts at the FIH stage against the critical requirement of ensuring product quality and patient safety. Figure 2. IQ Bio CMC use of closed-system transfer devices with biologics workshop.

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