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Clinical Grade Pharmaceuticals
Last Updated: 2026-02-05 15:23:37
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 (2006) "Biopharmacetical benchmarks" and list of approved recombinant proteins. Nature Biotechnology 24: 769 - 776, including tables. 3) B. Leader et al. (2008) "Protein therapeutics: a summary and pharmacological classification". Nat. Rev. Drug Discov., 7: 21-39 4) EMEA Dossier for Humira, with a special focus on: - 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
Lecture Notes
Chapters 11-14 of the Immunobiology VI book (Janeway et al.)G. Walsh (2006) "Biopharmacetical benchmarks" and list of approved recombinant proteins. Nature Biotechnology 24: 769 - 776, including tables.B. Leader et al. (2008) "Protein therapeutics: a summary and pharmacological classification". Nat. Rev. Drug Discov., 7: 21-39EMEA Dossier for HumiraHand-outs
Literature
Chapters 11-14 of the Immunobiology VI book (Janeway et al.) G. Walsh (2006) "Biopharmacetical benchmarks" and list of approved recombinant proteins. Nature Biotechnology 24: 769 - 776, including tables. B. Leader et al. (2008) "Protein therapeutics: a summary and pharmacological classification". Nat. Rev. Drug Discov., 7: 21-39 EMEA Dossier for Humira Hand-outs
General Information
- Language
- English
- Levels
- MSC
- Frequency
- Yearly recurring
Examination
- Type
- session examination
- Mode
- oral 15 minutes
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise | Clinical Grade Pharmaceuticals |
|
3 h weekly |