About the founder
Carsten Weber has more than 30 years of pharmaceutical industry experience and specializes in
CMC product development across all stages of discovery and development.
Through mid 2022, he was Senior Director in Sanofi´s drug product R&D organization, where he held different roles including head of pharmaceutical development NCE and NBE and the GMP parenteral pilot plant, and global head of innovation and pharmaceutical excellence. At Abbott/Abbvie he held the role of global head for parenteral process and formulation development, where he was responsible for CMC technical strategy and execution for parenteral molecule programs and combination product programs. He held additional responsibility in biologics patent strategy.
Carsten founded the Antaran Research Institute in 2022 to leverage his technical and leadership expertise to help small and medium sized biopharmaceutical companies develop novel therapeutic assets and delivery systems through early and late-stage development. Carsten brings a unique breadth of CMC experience including support of biologics discovery teams for candidate selection, drug and device delivery system technology assessment, combination product development and CMC development strategies leading to IND/NDA/CTD regulatory submissions.
Experience and Qualifications
- 33 years in pharmaceutical drug product development beginning with ORPEGEN, Knoll Pharma, Abbott/Abbvie and Sanofi
- 30 years in Leadership of Scientists and Engineers engaged in CMC product development
- Extraordinary breadth of CMC experience, including biopharmaceutical support of biologics discovery teams, solid-oral formulation development, novel drug delivery technology evaluation, drug/device combination product development,
- Ph.D., Protein Chemistry, Ruhr Universität Bochum, Germany
Specific Technical Expertise
- Translation of early protein characterization data into comprehensive drug-like properties and respective developmental risk assessment for candidate selection for pharmaceutical development
- Novel platform approaches for fast-to-clinic programs
- Sterile manufacturing technology development and transfer to GMP facilities
- Due diligence of in-licensing opportunities – Critical review and risk assessments of CMC data packages for assets; and applicability of formulation/delivery device technology
- Innovation strategy, End-to-End integration
- Product development strategies encompassing:
> Science- and risk-based formulation approach based on dose and biopharmaceutic properties for rapid clinical assessment (FIH through clinical PoC)
> Drug Delivery technology strategies to formulate biologic drugs for multi dose containers and respective injection systems
> Biologics high dose delivery technologies
> Deep expertise in drug product stability enhancing technologies (lyophilization, spray drying, prilling)
> Commercial process/formulation development and manufacturing strategy, including data package to support regulatory approval
> CMC team leadership/project management
> Common Technical Document module 3 authoring and review