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www.biopharminternational.com March 2021 eBook BioPharm International 25 perspective. Regulatory agencies, pharmacists, and CSTD manufac- turers were invited to present at the workshop to ensure participa- tion from key stakeholders. Resources provided through IQ (workshop organization/funding, rapid approval of presentations and general workshop support) enabled WG subject matter experts to focus on the science behind CSTD concerns and accomplish a goal that would have been dif- f ic u lt for a single compa ny to achieve on its own. In alignment with IQ strategic objectives, the work s hop p r ov id e d a ne ut r a l forum for the member companies to present a unified scientific posi- tion on CSTD use with biologics. The workshop highlighted con- cerns and communication gaps regarding CSTD use including: • Technical issues that impact product qualit y/dosing (e.g., hold-up volu me va r iabi l it y, stopper coring) • Inconsistent/inappropriate use of CSTDs with USP <800> applied more broadly than required • Absence of proper CSTD train- ing procedures • Healthcare providers relying on CSTD manufacturers for drug compatibility data • Absence of a universal standard for CSTD testing for biologics (e.g., ASTM standard) • I nc on si s te nt i nte r pr e t at ion of evolv ing reg u lat ions a nd device design inputs for biolog- ics compared to small-molecule products. The workshop discussion made it clear that each stakeholder had differing but equally important priorities, and that there was a need for further collaboration to achieve alignment 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 perspec- tive on product-agnostic and prod- uct-specific challenges associated with CSTDs. Importantly, the data presented by IQ highlighted poten- tial quality and patient impact of CSTD use and that a strong part- nership between pharma compa- nies 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 stake- holders, and resulted in discussions in ot her for ums includ ing t he Association for the Advancement of Medical Instrumentation, 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 discussion and learnings. Continued stake- holder disc ussions w ill f ur ther alignment on CSTD use with bio- logics and highlight IQ's role as a forum for enabling cross-stake- holder collaboration. PHASE-APPROPRIATE SPECIFICATIONS I n t e r n a t i o n a l C o u n c i l f o r H a r m o n i z a t i o n o f Te c h n i c a l Re qu i re me nt s for Reg i st rat ion of Pha r maceut ica ls for Huma n Use (ICH) Q6B, Test Procedures and Acceptance Criteria for Biotechnological/ B iolog ical Pro d u ct s (9), do es not address the use of science-and risk- based development approaches for establishment of specifications. The lack of clear globally harmo- nized guidance for how to com- bine ICH Q6B and science and risk-based approaches per ICH Q8– Q11 (10–13) creates challenges for implementation of fit for purpose first-in-human (FIH) and commer- cial specifications. The challenge for FIH specifica- tions is the lack of product expe- rience early in development and the need to utilize prior knowledge to inform on attribute impact. For commercial products, basing spec- ifications solely on characteristics outlined in ICH Q6B (primarily clinical experience range) often results in inappropriate specifica- tion limits that adversely impact the shelf-life, results in rejection of lots with acceptable qualit y, and limits patient-centric lifecycle improvement efforts 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 acceptance of a science and risk- based patient centric approach for specification setting for biologics. The initial focus of the WG was the development of FIH platform specifications for monoclonal anti- bodies (mAbs) and antibody-drug conjugates (ADC). Subsequently, the WG turned its attention to identi- fying common industry strategies for applying a science- and risk- based approach to establishment of patient-centric commercial specifi- cations for standard biotherapeutic products such as mAbs and ADCs. The WG used a combination of l iterat u re rev iew, pre - com- petitive team discussions, and an IQ-supported blinded survey of member companies to gather infor- mation on specification-setting current best practices. The survey allowed for a comprehensive, anon- ymous assessment of the methods and acceptance criteria typically used by member companies for FIH biologic products. For the commer- cial specification effort, team discus- sions were used to identify common Regulatory Sourcebook Quality Collaboration