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M. Sc (Integrated Biotechnology)
GENERAL BIOTECHNOLOGY
SEMESTER -X
Name of Course: BIOTECHNOLOGY MANAGEMENT
Course Number: IG-GBT 1003
Unit:1
Unit: 2
Formulation, Quality requirements in the biotech industry, GMP and GLP, The
regulatory process (regulatory affairs)
Unit: 3
Set up of fictitious biotech company based on a project study in terms of a business plan
which is presented both orally and as a written plan.
Reference books:
1. Moses, V. and Cape, R.E., Biotechnology: The science and the business.
Harwood Academic Publishers. ISBN: 9789057024061 (1999)
2. Hine, D. and Kapeleris, J., Innovation and Entrepreneurship in Biotechnology, An
International Perspective. Concepts, Theories and Cases. Edgar Elgar Publishing
Limited. ISBN-10: 1 84376 584 5 (2006)
3. Dobers, P. and Wikander, S., BioNova: Building a Biotech Company.
Studentlitteratur. ISBN: 9144037767. (2004)