Dr. Ronan O’Kennedy is a Senior CMC Consultant with over 25 years’ experience in biopharmaceutical development and technology transfer. He specialises in mammalian and microbial cell upstream process development, statistical-based process modelling, and Quality by Design (QbD). His career spans academia, industry and consultancy, including senior technical leadership roles at GlaxoSmithKline and Fujifilm Diosynth Biotechnologies, giving him extensive experience in bioreactor design, scale-up and technology transfer for GMP manufacture of biologics.
Expertise: Primary Service Skillsets
Biologics Process Development
- Mammalian and microbial cell upstream process development, from lab through pilot to commercial manufacturing scale
- Bioreactor design, scale-up and technology transfer for GMP manufacture of biologics
- cGMP manufacturing and technical transfer of upstream processes for clinical and commercial supply
Statistical Process Modelling & Quality by Design
- Design of Experiment (DoE) methodologies and multivariate analysis
- Data-driven bioprocess modelling and research data management
- Embedding QbD principles to build quality and robustness into biologics manufacturing
CMC & Strategic Consultancy
- Strategic planning, due diligence and CDMO management
- Technical and strategic consultancy across biopharmaceutical process development
- Validation and regulatory support for biologics manufacture
Additional Technical Specialisms
- Single-Use & Stainless-Steel Bioreactor Systems: Expertise across both platforms for mammalian and microbial fermentation at all scales
- Ambr Micro-Bioreactor Platforms: Application for cell line development (CLD) and process characterisation studies
- Media Optimisation & Lab Equipment Configuration: Configuring laboratory equipment and optimising media to support robust process development
- Monoclonal Antibodies, DNA Vaccines & Peptide Therapeutics: Process development experience across diverse biologics modalities for clinical manufacture
- Bioreactor & Facility Design: Specification, design and commissioning of R&D and GMP-scale cell culture facilities, including SCADA systems
To learn more about Dr. Ronan O'Kennedy, read here.
If you would like to discuss your project with Ronan or require specialist advice please get in touch.
