Sumant Chaubey
Bills Biotech, India
Title: CHALLENGES IN PROCESS DEVELOPMENT, SCALE UP, BULK MANUFACTURING OF LOW VOLUME HIGH VALUE BILOGICS & BIOSIMILARS: GLOBAL AND INDIAN PROSPECT
Biography
Biography: Sumant Chaubey
Abstract
The biologics market consists primarily of vaccines, monoclonal antibodies, recombinant proteins and diagnostics. Global pharmaceutical market projected of the growth rate 12%, Growth in biopharmaceutical market,to reach US$138 bn by 2014,dominated by products from mammalian cell cultures (>75%). Global biosimilars market ≈ $19.4 billion by 2014, growing at an expected CAGR of 89.1% from 2009 to 2014.By 2015, sales of biosimilars in US are expected US$1.9-2.6 billion, up from US$378 million in 2011.There is great opportunities in biopharmaceuticals, novel biologics & biosimilar r-proteins, Vaccines development and process parameter set up.Different scale-up criteria have been used depending on the type of fermentation and bioreactors. Growing mammalian cells in fermenters/bioreactors and to produce the protein of interest is a very cautious process and process parameters like pH or dissolved oxygen concentration need to be controlled very strictly to corroborate the consistency of a product. Minor deviations of the predefined process parameters can easily result in changes of product quality attributes like glycosylation, aggregation, c-terminal clipping or acidic variation, which can affect the pharmacokinetics of the protein e.g. case study for eryhtropoetin,Darbepoetin,Mabs etc..In reality scale-up of laboratory and pilot-plant data to commercial size industrial bioreactors is complicated.No actual data or correlation or exisiting formula is fixed for scale-up. Different people use different scale-up criteria to design commercial size bioreactor systems.In fermentation industry there are a lot of trade secrets on scale-up of bioreactors and fermentors , and very few published results.