Regulatory science behind drug substance & drug product specifications of monoclonal antibodies
Key Learning Outcomes
- Understand the scope and purpose of ICH Q6B, including how it defines specifications for therapeutic proteins and monoclonal antibodies, and how these specifications relate to but differ from detailed characterisation performed during drug development.
- Learn to construct a comprehensive specification framework that covers the five core quality attribute categories: appearance, identity, purity and impurities, quantity and potency, and additional product-specific tests for parenteral biologics.
- Discover the differences between product-related substances, product-related impurities, and process-related impurities, and how risk assessment determines which attributes should be included in drug substance versus drug product specifications.
- Explore the analytical methods supporting each quality attribute, from peptide mapping and ion exchange chromatography (IEC) to bioassays and size exclusion chromatography (SEC), and understand when to use compendial versus in-house methods.
Event Overview
This session by Dr Patanachai “Kong” Limpikirati provides a comprehensive, academically grounded introduction to setting specifications for therapeutic proteins under ICH Q6B, with a particular focus on monoclonal antibodies. The presentation details the regulatory and scientific background for specifications, explaining why they are necessary, what they aim to achieve, and how they fit into the broader quality control framework of GMP drug development. It then systematically examines each quality attribute category that a complete specification must include.
A key theme is the significant distinction between detailed characterisation and specification testing. While extensive characterisation is vital during development to deepen product understanding, specifications represent a carefully chosen, QC-compatible subset of these tests: rigorous enough to guarantee patient safety, yet practical enough for routine implementation in a GMP environment. The session adopts the European Pharmacopoeia monograph for infliximab and a mock-up specification for a model monoclonal antibody to illustrate these ideas with tangible, real-world examples.
The presentation then explores each quality attribute category in detail. For identity, the session covers confirmation of primary structure via peptide mapping and verification of higher-order structure via potency and bioidentity testing. Concerning purity and impurities, it differentiates charge variants, size variants, glycan profiles, host cell proteins, residual DNA, and process-specific impurities, explaining which belong in drug substance specifications and which in drug product specifications, along with the reasons. In terms of quantity and potency, it discusses both physicochemical protein content assays and functional bioassays, emphasising that potency is an essential, non-negotiable component of specifications for biologics. The session concludes with additional parenteral-specific tests, including pH, osmolality, particulate matter, microbial contamination, and other dosage form-specific requirements.
Who Should Attend?
Anyone involved in biologics development, quality, or regulatory affairs seeking to establish a comprehensive understanding of specification design for therapeutic proteins and monoclonal antibodies based on ICH Q6B principles.
- Analytical Scientists and Method Development Chemists working on biologics
- Quality Control and Quality Assurance Professionals in biopharmaceutical settings
- Regulatory Affairs and CMC Submission Specialists
- Biopharmaceutical Development Scientists new to specification setting
- Validation and Compliance Scientists
- Academic Researchers and Postgraduates entering the biopharmaceutical industry
- R&D and Technical Operations Managers overseeing biologics programmes
Unlock Additional Educational Resources
Register today for Kong’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. Patanachai “Kong” LimpikiratiLecturer, Department of Food and Pharmaceutical ChemistryFaculty of Pharmaceutical Sciences, Chulalongkorn University (Thailand)Dr Patanachai Limpikirati is a lecturer on medicinal chemistry and pharmaceutical analysis at the Faculty of Pharmaceutical Sciences, Chulalongkorn University. His research specialises in the analytical characterisation of biologics, mass spectrometry-based pharmaceutical analysis, and structural studies of protein therapeutics, including both primary and higher-order structures. He has secured multiple research grants to advance mass spectrometry techniques for protein therapeutic analysis. He has published over 20 peer-reviewed articles (Scopus h-index: 11). Besides his research, he actively mentors students and teaches graduate and undergraduate courses in pharmaceutical analysis, biopharmaceutical analysis, and regulatory sciences.
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