Quality control in Biopharmaceutical industries (CH865)


M.Tech (IBT)


Elective Courses (Ele)

Credits (L-T-P): 

03 (3-0-0)


Introduction to GMP, General considerations in quality of bioproducts (enzymes/vaccines/insecticides/r-DNA product etc.) such as molecular identity, potency, purity and stability, toxicity, immunogenecity and consistency. Physical and biological containment, facilities for experiments dealing with recombinant cells and viruses. General scientific considerations for assessing possible risks of viral/bacterial insecticides and recombinant organisms in large scale particles.


Total Quality Environmental Management : An ISO 14000 Approach Vasanthakumar N. Bhat, Quorum Books, 1998
ISO9000 for Better Business: Using ISO 9000 As a Foundation for Total Quality management Jack E. Small,Lanchester Press Inc, 1996
Bioprocess Monitoring and Control (Hanser Series in Biotechnology) Marie-Noelle Pons,John Wiley & Sons Inc 1993


Chemical Engineering

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Dr. I. Regupathi, Professor and Head
Department of Chemical Engineering, NITK, Surathkal
P. O. Srinivasnagar, Mangalore - 575 025
Karnataka, India.

  • Hot line: +91-0824-2474057

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