Biopharmaceuticals, i.e., recombinant proteins biomanufactured for human therapeutics, are presently produced in India using all three biocatalytic platforms: bacteria, yeast, and animal cell cultures. Although the spectrum of commercial products – human insulin, interferons, monoclonal antibodies, erythopoietin, blood clotting factor enzymes, and colony-stimulating factors for treating neutropenia – is limited, investment is continuing to establish both “research parks” and manufacturing facilities in India. Within the next 5-10 years, Indian companies are expected to be major players in the production of biopharmaceuticals, especially if a global market for biogenerics develops. After a survey of published accounts of India’s research in upstream and downstream bioprocess technologies for biopharmaceuticals, detailed consideration is given to the scientific and technical challenges posed by animal cell cultures in the light of India’s extensive experience of microbial fermentations for both enzymes and small molecule products: media formulations and nutrient use, the inclusion of “complex” ingredients of plant origin, bioreactor control, and the improved understanding of the complexities and subtleties of animal cell line metabolism.
About the Author:
David M. Mousdale
Glasgow G1 1XW United Kingdom
With an Honours Degree in Biochemistry from the University of Oxford and Ph.D. from the University of Cambridge, the author has worked on the technical and economic improvement of commercial bioprocesses since 1985. Both microbial and animal cell systems have been subjects for international collaborative projects in India, Japan, Korea, Europe, and the United States. Commercial products have included enzymes (proteases, amylase, cellulase and amyloglucosidase), antibiotics, vitamins, novel secondary products, and recombinant proteins including monoclonal antibodies and erythopoeitin.