RECOMBINANT PHARMAPROTEINS
Advances in Production Technology

Part I - Vienna, September 24-26, 2007

Course content

Final Program
Topic Content
1 Raw Materials Sampling, storage, delivery, protocols
2 Equipment Washing, CIP, heat sterilization, autoclaving
3 Media preparation Facilities, water supply, filtration, on-line mixing, storage
4 Cell expansion and cell banks Facilities and equipment, cell bank preparation, filling and storage
5 Upstream, GMP and Regulations Fermentation and separation, equipment and methods
6 Downstream Protein Purification: Chromatography, Ultrafiltration, Electrophoresis
7 Filling Preparation of Product and Vials, disposing, lyophilzation, capping and labelling
8 Qualification and validation, hygiene plan Organization of a validation plan, implementation from early planning. Interaction with the future users of the plant.
9 Documentation Organisation of a comprehensive project documentation including the desingn automatic data acquision.
10 Quality Control In process and product analytics, process and media QC


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