Expert Forum
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 settings
Overview 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 settings
Expert Forum Panel Discussion
Part 2: ICH Q6B & challenges in setting patient-centric specifications
Patient-Centric Commercial Specificaons for Biotherapeutic Products, Strategies and Case studies by Dr. Eric Rozet
Part 2: ICH Q6B & challenges in setting patient-centric specifications
Insights on specification setting challenges and opportunities by Dr. Simona Cianetti
Part 2: ICH Q6B & challenges in setting patient-centric specifications
Expert 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 recognised for her extensive expertise in quality control and analytical technologies. She currently serves as the President and Chief Consultant of Miliar BioPharma Solutions, a consulting firm she established after a successful career in various leadership roles.
Carmilia’s professional journey includes significant positions at prominent companies such as BioMarin Pharmaceutical Inc., Ajinomoto Bio-Pharma Services, Gilead Sciences, Merck & Co., Inc., and Amgen Inc. In these roles, she focused on managing biologics programmes across multiple therapeutic areas, including oncology, hematology, rheumatology, and renal diseases.
Carmilia earned her Bachelor of Science degree in Biology from the University of Puerto Rico, Mayagüez. She then pursued a Ph.D. in Microbiology and Immunology at Temple University’s Lewis Katz School of Medicine. Her postdoctoral research was conducted at St. Jude Children’s Research Hospital in Memphis, Tennessee.
Beyond her professional and academic achievements, Carmilia is actively involved with CASSS – Sharing Science Solutions, an organisation dedicated to advancing scientific knowledge in the field of biopharmaceuticals. She has been a member of the CASSS Board of Directors since 2021 and has contributed to multiple committees, including WCBP, the CMC Strategy Forum for Latin America and North America, and the Symposium on mRNA Therapy Products.
Carmilia’s dedication to technical innovation and quality control in biopharmaceuticals has significantly contributed to ensuring patient access to superior medical treatments. Her leadership and expertise continue to positively influence the industry.
Moderators
Prof. Dr. Cari Sänger-van de Griend
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
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