Clinical Grade Pharmaceuticals

Abstract

The course consists of three parts.First, the students will complete their basic training in pharmaceutical immunology. Second, they will be exposed to the most relevant issues related to the GMP production of therapeutic proteins. Third, they will address case studies on product quality management issues across the pharmaceutical industry supply chain

Objective

The course will provide students with essential information about the development and quality-assurance of clinical-grade pharmaceuticals (both small molecules and therapeutic proteins)

Content

PART 1 1) Chapters 11-14 of the Immunobiology VI book (Janeway et al.) 2) G. Walsh (2003) Nature Biotechnology 21, 865-870 "Biopharmaceutical benchmarks" (or a more recent article; the list of approved biopharmaceuticals comes out in nature Biotechnology every third year) 3) The following aspects of the GMP manufacture of therapeutic proteins (documentation: FDA Dossier for Humira): - Expression systems - GMP facilities for protein production - Cell banking - Fermentation - Purification - Filling and formulation - QC and stability PART 2 4) Case studies on product quality management issues across the pharmaceutical industry supply chain: - active ingredient supply - clinical trials supply - analytical development - scale up & technical transfers - galenical manufacturing - primary & secondary packaging - quality control & release - transportation and storage - good distribution practice - sampling and stability - complaint management and recalls - Authorities, authorizations and inspections

Resources