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Analytical Method Comparability Studies: Expert Panel Discussion on Instrument and Technology Changes
Expert Insight & Answers | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria accordingly.
Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections
Meet the Expert: Dr. Timothy Blanc | Explore the current lack of regulatory guidance for electropherogram integration and discover how industry-wide harmonisation of guidelines, benchmarks, and software could strengthen analytical reliability.
Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices
Expert Insight & Answers | Understand how specification setting for biopharmaceuticals requires multidisciplinary input, and learn how release and shelf life specifications are determined and differentiated based on product stability data and process capability.
Patient-Centric Specification Setting: Beyond Batch Data
On-Demand Presentation by Dr. Simona Cianetti (GSK) | Understand the principles of patient-centric specification setting and learn how clinical exposure data, process characterisation, and modelling can be combined to establish clinically justified acceptance criteria that go beyond batch data and manufacturing variability.
Regulatory science behind drug substance & drug product specifications of monoclonal antibodies
On-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University) | Learn how to construct a comprehensive specification framework for monoclonal antibodies under ICH Q6B, covering the five core quality attribute categories and understanding which tests belong in drug substance versus drug product specifications.
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Meet the Expert: Dr. Anne Ries | Explore a practical benchmark example comparing two icIEF instruments, and gain a reusable framework to support lifecycle management of analytical methods in regulated environments.
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
On-Demand Presentation by Dr. Anne Ries (Boehringer Ingelheim) | Discover how historical QC control chart data can replace prospective experiments on the old instrument to set statistically robust acceptance criteria, illustrated through a real-world icIEF platform transition across multiple commercial products.
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
On-demand Presentation | Gain an overview of ICH Q6B and current practices for setting specifications for biopharmaceuticals, including monoclonal antibodies and advanced therapies, and understand the statistical and analytical considerations involved.
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