1. BRIGHTICE
www.brightice.org
CHALLENGES IN PROCESS DEVELOPMENT, SCALE UP, .
BULK MANUFACTURING OF LOW VOLUME HIGH VALUE BILOGICS &
BIOSIMILARS: GLOBAL AND INDIAN PROSPECT.
Dr 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
aioreactors and fermentors , and very few published results.
Bills Biotech Pvt Ltd
Biography
Dr Sumant Chaubey, Ph.D
Currently holding the position of Chief Operating Officer & Chief Technical Officer at Bills Biotech Pvt Ltd, Vadodara,GJ
(Ph. D – Molecular Microbiology - Maharaja Sayajirao University, Vadodara, M. Sc-Biotechnology- Maharaja Sayajirao University, Vadodara,
Graduation B.Sc.- Zoology and Chemistry -Banaras Hindu University,Varanasi)
Industrial Position Held:
1. Head of R&D & Sr. GM – Biologics and Biosimilar at Virchow Biotech Pvt Ltd, Hyderebad,
2. Head & Asst. General Manager - Biopharma operation at Microtherapeutics Research labs Pvt ltd, Chennai,
3. Sr .Manager & Head - Biosimilar and Biologics Development, Research & Training ,process consultancy at BiOZEEN, Bangalore,
4. Senior Group leader - Fermentation and Synthesis R & D at Concord Biotech Limited,
5. Senior Executive - Downstream at Intas Biopharmaceuticals
Summary of Experience:
More than 15 years industrial experience on process development and production of following molecules e.g. GCSF, Erythropoetin, IFN-2b, IL-
2, rH-GCSF, PEG-GCSF, r-URATE OXIDASE, PEG-UOX, r-INSULIN,r-GLARGINE,r-PTH,r-EK, r-CBP, L-ASPARAGINASE,r-tPA,r-EPO,r-
Protein
Award Received :
1. Department of Biotechnology India fellowship Award during Post Graduation,
2. Meritorious Fellowship Award during Ph.D
3. FEMS Grant Award-2011,
4. Asian PGPR Best Research Work Award-2010, ,
5. Key Note Speaker at Bioprocess India-2014,IIT-Mumbai.