Patient-Centric Specification Setting: Beyond Batch Data
Key Learning Outcomes
- Understand the principles of patient-centric specification setting: what to control, how to establish clinically relevant limits, and how to develop an overall control strategy that extends beyond final product release testing.
- Learn how the ongoing revision of ICH Q6A and Q6B is shifting the industry from batch-data-driven acceptance criteria towards science- and risk-based approaches that incorporate prior knowledge, process consistency monitoring, and clinically justified limits.
- Discover how clinical exposure data, product and process characterisation, batch history, and modelling work together to determine acceptance criteria, and why no single factor alone is sufficient to establish a robust specification.
- Explore three vaccine case studies: clinically proven specifications for a liquid formulation, potency specification setting using dose-response curves, and excipient specification setting via QbD, demonstrating how patient-centric principles are practically applied to accelerate development without compromising safety.
Event Overview
This session by Dr Simona Cianetti addresses one of the most important and often overlooked challenges in biopharmaceutical development: establishing specification acceptance criteria that are truly based on patient safety and therapeutic effectiveness, rather than being solely influenced by manufacturing variability or incremental increases from phase to phase. Drawing on vaccine development experience and the growing ICH Q6 framework, the presentation argues for a fundamental change in how the industry approaches setting specifications.
The session begins by establishing the regulatory foundation, the ICH Q6 definition of specifications, the justification requirements at each development stage, and the risks of setting overly restrictive criteria too early before understanding the product and process fully. It then introduces the concept of patient-centric specifications practically: identifying which critical quality attributes directly affect safety and efficacy, defining acceptance ranges based on clinical evidence rather than process capability alone, and integrating those limits into a comprehensive control strategy that includes in-process controls, process analytical technology, and real-time release alongside final product testing.
A considerable part of the session focuses on the ongoing ICH Q6A/Q6B revision, which is formalising many of these principles, including the distinction between specification limits and process consistency monitoring, options for situations with limited batch experience, and the enablement of modelling, statistics, and real-time release approaches.
The presentation then covers three detailed vaccine case studies that illustrate these concepts. The first shows how artificially aged clinical lots were used to validate end-of-shelf-life specifications for a liquid vaccine formulation, allowing an accelerated development timeline with a single clinical study. The second explores the challenges of establishing potency acceptance criteria using dose-response curves from phase two trials. The third demonstrates how QbD optimisation of excipient concentration can produce clinically justified ranges that are much wider than process variability alone would suggest supporting manufacturing flexibility while ensuring patient safety.
Who Should Attend?
Anyone involved in biologics or vaccine development, quality strategy, or regulatory submissions who aims to transition from batch-based specifications to a clinically grounded, patient-centric approach.
- Analytical Scientists and Method Development Chemists in biologics and vaccines
- Quality Control and Quality Assurance Professionals
- Regulatory Affairs and CMC Submission Specialists
- Vaccine and Biopharmaceutical Development Scientists
- Clinical and Preclinical Scientists contributing to the CMC strategy
- Statisticians and Modelling Scientists supporting specification development
- R&D and Technical Operations Managers overseeing biologics and vaccine programmes
Unlock Additional Educational Resources
Register today for Simona’s presentation and gain access to exclusive bonus content, such as the insightful panel discussions on “Overview of ICH Q6B guideline and current practice on specification settings” and “ICH Q6B & challenges in setting patient-centric specifications”.
Dr. Simona CianettiSenior Director, Head CMC Analytical Projects, Portfolio and Technology DeliveryGSK (Italy)Simona Cianetti currently leads the Analytical Product Leaders team at GlaxoSmithKline (GSK). She holds a Master's degree in chemistry and a PhD in biophysics from Paris VI University. With over 20 years of experience in the pharmaceutical industry, Simona has worked in R&D across small molecules, large molecules, and vaccines. Throughout her career, she has held various leadership roles in projects and departments, contributing to the development and advancement of pharmaceutical products.
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