Fermentation and Bioprocessing

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Introduction

The term “Biopharmaceutical” refers to drugs that have unique qualities in the way that they derived and manufactured as opposed to traditional drug products. Biopharmaceutical are protein-based (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purpose and are produced from genetically altered microorganisms or may come from blood or blood plasma products (usually referred to as biologics). The first such substance approved for therapeutic use was biosynthetic human insulin made via recombinant DNA technology. Now a day’s almost all the biopharmaceutical products are manufactured commercially through various fermentation routes on using genetically engineered microorganisms like E.coli, yeast, mammalian cell and insect cell culture maintaining various regulatory compliances since these products are marketed in regulated markets of different countries. The present domain Fermentation and Bioprocessing comprehensively deals with theoretical and practical aspects of upstream and downstream of Biopharma manufacturing processes keeping cGMP in mind.

Description

In the present BTFS curriculum, the domain Fermentation and Bioprocessing has been divided into four modules viz. Upstream Process, Downstream Process, Biopharma Facility Engineering and Regulatory affairs. This domain deals with the production of therapeutic proteins on using different expression systems as well as high cell density fermentation including media selection, preparation and sterilisation, fermenter functional design, sterilization in place and sterilization process validation, fermenter inoculation and maintenance of different fermentation parameters, scale up of fermentation process, fermenter harvest and cleaning process validation. For animal cell culture, media preparation and sterilization by filtration, sub-culturing, suspension culture and monitoring, monitoring of bioreactor cultures. In downstream processing, familiarization with chromatography equipment, column packing methods, column equilibration, and operation of tangential flow filtration as well as its cleaning and sanitation, dead end filtration will also be part of the curriculum. In addition, regulatory requirements of different countries and cGMP requirements for the production area of biopharmaceuticals will also be covered in the present domain.

Application

Pharmaceutical proteins produced via fermentation in transgenic microbes or mammalian cell culture systems provide economical systems for production of therapeutic proteins. Fermentation systems can be scaled up to produce quantities of pharmaceuticals that are difficult or impossible to produce via traditional methods. In addition rapid growth rate and high productivity, higher product content per unit of cells, the process occupy little land area, production is independent of seasonal variations and climatic conditions has added advantages to the fermentation process. Some of the Biopharma products are produced commercially through fermentation routs are - Human insulin, Streptokinase, Erythropoietin, Hepatitis B Vaccine, Human growth hormone, Interleukin, GCSF, GMCSF, Alfa-Interferon, Gamma Interferon etc.

Biopharma Industries

Biocon, Serum Institute of India, Panacea Biotech, Reliance Life Sciences, Shantha Biotechniques, Indian Immunologicals, Bharat Biotech, Cadila Health Care, Intervet India, Intas Biopharma, Eli Lilly, Hafkine Biopharma, Glaxo Smith Kline, Novo Nordisk etc.

Future Prospects

In the fastest growing Biotech Industry, Biopharmaceuticals consist of about 62% of the $3 billion generated by the Biotech Industry in financial year 2009/10. According to the 9th Biospectrum-ABLE Biotech Industry Survey 2011, the industry has grown by 21.5%, slightly less than $4 billion in financial year 2010/2011