Implementing Phase Appropriate GMP for Manufacturing Biologics and Cell Therapy Products
Outline of Course Agenda
Phase Appropriate GMP for Biologics Manufacturing is a subject that has received much attention in the past few years. But what does it mean and how can it be implemented? What does Phase Appropriate GMP look like at Phase 1, Phase 2 and Phase 3, and how does it differ when the manufacturing is outsourced?
Some of the most exciting new products in development are coming from academia and are being championed by small start-up companies which operate in a “virtual” mode, by outsourcing most or all of their regulated activities. Nevertheless even small companies need to be aware of the GMP expectations for their products, and will need to evolve an appropriate pharmaceutical quality system as they progress through the different phases of development.
This short course will look at the challenges to implementing phase-appropriate GMP and pharmaceutical quality systems for both large and small companies and in particular it will take a close look at the specific challenges faced by developers of cell therapy products. It will also look at some of the solutions to some of these challenges. Topics covered will include:
- Phase Appropriate GMP - The Regulatory Background
- The Challenges for the Outsourcing
- Specific Considerations for Cell Therapy Products
- The Impact of Single-use Technologies
- Automating the Pharmaceutical Quality System and Maintaining Data Integrity
Trevor Deeks, PhD, QA/QC and GMP Consultant, Deeks Pharmaceutical Consulting Services, LLC
Trevor has 39 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a PhD in Peptide Chemistry and has extensive expertise in aseptic processing, and in a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cell-based products.
He has practiced as a QP since 1983 and his QP experience includes commercial batch release, investigational medicinal products and “Specials.” He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.