The document discusses challenges in developing, scaling up, and bulk manufacturing of low volume, high value biologics and biosimilars globally and in India. It notes that the global biopharmaceutical market is projected to reach $138 billion by 2014, dominated by products from mammalian cell cultures. Biosimilars market is expected to reach $19.4 billion by 2014, growing at 89.1% annually from 2009 to 2014. Strict control of process parameters like pH and dissolved oxygen is needed during mammalian cell growth to ensure product consistency. Scaling up laboratory and pilot data to commercial size bioreactors is complicated with no set formula and different approaches used. The biography section provides details on the author's 15+ years of experience

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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.