Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B

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Part 1: Overview of ICH Q6B guideline and current practice on specification settingsOverview of the ICH Q6B Guideline - Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics by Dr. Patanachai “Kong” Limpikirati

Part 1: Overview of ICH Q6B guideline and current practice on specification settingsExpert Forum Panel Discussion

Part 2: ICH Q6B & challenges in setting patient-centric specificationsPatient-Centric Commercial Speciﬁcations for Biotherapeutic Products, Strategies and Case studies by Dr. Eric Rozet

Part 2: ICH Q6B & challenges in setting patient-centric specificationsInsights on specification setting challenges and opportunities by Dr. Simona Cianetti

Part 2: ICH Q6B & challenges in setting patient-centric specificationsExpert Forum Panel Discussion

Presenters / Panellists

Dr. Patanachai “Kong” Limpikirati Lecturer, Department of Food and Pharmaceutical Chemistry Faculty 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.

Dr. Eric Rozet Lead Statistician GSK (Belgium) Eric Rozet is the Lead Statistician at GSK (Belgium). He has over 20 years of experience in discovery, pre-clinical, and non-clinical statistics, with a particular focus on statistical aspects related to (bio)assays and (bio)processes, including development, optimisation, validation, transfers, manufacturing, and stability. He trains statisticians and analysts in the Bio-Pharmaceutical Industry on topics such as optimisation, validation, robustness, and the transfer of analytical methods and processes. Eric also trains statisticians in Bayesian modelling and Designs of Experiments. He is the author of more than 100 articles and book chapters in applied statistics and regularly gives conferences on these subjects. Eric holds a B.Sc. degree in Bio-engineering, a Master's degree in Biostatistics, and a PhD in Pharmaceutical Sciences.

Dr. Simona Cianetti Senior Director, Head CMC Analytical Projects, Portfolio and Technology Delivery GSK (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.

Carmilia Jiménez Ramírez, Ph.D. President & Chief Consultant Miliar Biopharma Solutions (USA) Carmilia Jiménez Ramírez is an expert in quality control and analytical technologies. She is President and Chief Consultant of Miliar BioPharma Solutions, which she founded after a successful career in leadership roles. Her past positions include roles at BioMarin Pharmaceutical Inc., Ajinomoto Bio-Pharma Services, Gilead Sciences, Merck & Co., Inc., and Amgen Inc., where she managed biologics programs in oncology, hematology, rheumatology, and renal diseases. Carmilia has a B.S. in Biology from the University of Puerto Rico, Mayagüez, a Ph.D. in Microbiology and Immunology from Temple University’s Lewis Katz School of Medicine, and completed postdoctoral research at St. Jude Children’s Research Hospital.

Moderators

Prof. Dr. Cari Sänger-van de Griend Scientific Director BioQC Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.

Dr. Ewoud van Tricht Scientific Director BioQC Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.

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Resources

[GUIDELINE]
Specifications: Test Procedures And Acceptance Criteria For Biotechnological/Biological Products Q6b