Pharmaceutical Process Development

• Describe the production process for typical small-molecule pharmaceuticals.
• Describe the production process for typical biopharmaceuticals.
• Explain the principles of QbD and PAT
• Describe the development process and ‘life-cycle’ of a new pharmaceutical.
• Describe the latest developments in the field of pharmaceutical development and production processes.
• Explain the principles of LEAN manufacturing.
• Describe the different classes of pharmaceutical, biopharmaceutical, biosimilars and generics.
• Explain the principles of GMP manufacturing

Introduction – future pharmaceuticals with increased complexity; trend towards therapeutic proteins; trend towards continuous processes based on FDA requirements; Small molecule production – future pharmaceutical production, including semi-synthetic approaches (fermentation and biocatalysis) and continuous processes as well as technologies for improved sustainability; Biopharmaceutical production – future biopharmaceutical production, including fermentation, cell culture, antibody processing and downstream processing and single use technology, alternative hosts; Protein and peptide modification; Antibody-drug conjugates; Process Development – pharmaceutical process development paradigms, including F3; PAT and QbD: Process Analytical Technology (PAT) and Quality-by-Design (QbD), GMP, LEAN.

Lectures, exercises and group work