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SARDAR PATEL UNIVERSITY

M. Sc (Integrated Biotechnology)
GENERAL BIOTECHNOLOGY
SEMESTER -X
Name of Course: BIOTECHNOLOGY MANAGEMENT
Course Number: IG-GBT 1003

Unit:1

What is biotechnology? Orientation of the global biotech industry, Patent

Unit: 2

Formulation, Quality requirements in the biotech industry, GMP and GLP, The
regulatory process (regulatory affairs)

Unit: 3

Detailed laboratory case study of a biotechnology process including project planning.


Biotechnology management and entrepreneurship: Orientation of management
procedures in the biotech industry. Introduction of business operations in a start up
biotech company

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)

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