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cGMP Compliance for Biopharmaceuticals
29-30 October 2008
Basle, Switzerland
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
This Education Course is mainly concerned with the contents of international guidance documents and the draft of Annex 2 and special points which must be considered with regard to the development and production of bio-pharmaceuticals to assure the GMP compliance.
It covers the topics of routine and pre-approval inspection, registration in the field of biosimilars as well as in QC laboratory and production.
Furthermore the experience of biotech manufacturers as well as contract manufacturers will be highlighted by means of samples of clinical trial biologicals and fill and finish production.
The introduction to the new biotech facility and following site visit shows the practical implementation of GMP requirements.
Site Visit of the news Biotechnology Production Center at Roche
On the second day, we will visit the new Biotechnology Production Centre at Roche, Basle. It is a 40 metre high building with two basement levels and eight stories. It is a state-of-the-art facility for commercial production of therapeutic antibodies and other cell culture-derived products. The multipurpose design enables the production of two products at once in a capacity of 6 x 12.5 cubic metres of fermentation and two downstream processing lines.
Currently the active ingredient of Avastin is manufactured there. In the future it will also be used to manufacture some of the biopharmaceuticals that Roche now has in the pipeline.
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