Cross functional experience of over 30 years in managing research activities, coordinating with the project teams and enhancing bioprocess operations in R&D Molecular Biologist with demonstrated competence in wide range of functions viz. vaccine research, bioprocess development, analytical research, validation, quality control documentation and co-ordination of biotech drug development, especially monoclonal antibody-based therapeutics & fusion proteins.
He focused on CMC dossier preparation for successful filings in regulated markets (Japan, Europe, Australia and the US)
Overall responsibility for early-stage development of biosimilar drugs, including:
Development of bacterial clones: mAb fragments and non-mAb molecules cloned in bacterial systems using high cell density fermentation (>300 OD). Turn around for a mAb fragment product with highest productivity and yields in the industry and working on new molecules with high titers and reduced CoGs.
Development of mammalian clones: mAbs currently into development for regulated markets. High cell density, high titers with identified CQAs and addressed with establishment of biosimilarity index with the reference product. Improvisation of a mAb cell line to yield titers unmatched in the industry with the given quality.
Process Development: Improvement in process for two products using DoE approach for higher purity and recoveries.
Process Characterization: by qualification of scale-down model, determination of RPN for critical process parameters, OFAT and multivariate analysis for assurance of process robustness.
Process Validation: Seamless tech transfer of the developed process to manufacturing and assist in process validation.
Documents preparation and review for submissions to various regulatory authorities, especially PMDA, EMA FDA, & TGA.
Audit representation: Successfully faced audits from various international companies and regulatory agencies from R&D perspective.
Major contribution in dossier preparation (CMC section) and obtaining marketing approval in Japan and cGMP approval in Europe for Lupin’s flagship product.
Intellectual property assessment for product, process, formulation and method of use for various biosimilar molecules in the pipeline.
Project management with respect to product developmental timelines, budgeting, reduction in cost-of-goods and thereby increase return on investment.
Novel technologies evaluation and further development of pipeline.
Manpower development and optimizing FTEs.
He worked in various capacity for organisations like Avesthagen Ltd, Intas Biopharmaeuticals Ltd, National Dairy Development Board. Bestowed “Best Leadership” award by Intas Biopharmaceuticals, 2008-09
▪ Awarded Gold Medal by the Indian Veterinary Association for the best research article published in the Indian Veterinary Journal, 1993.
▪ Awarded Silver Medal for securing First Position in 2nd Year B.V.Sc. & A.H. by the Bombay Veterinary College in the year 1977.
Membership of Scientific Bodies
▪ Member (Life) – Society of Biological Chemists, India
▪ Member (Ordy) – Indian Dairy Association
▪ Member (Ordy) – Indian Society for Veterinary Medicine
▪ Member – Expert’s Advisory Committee constituted by the Govt. of Gujarat, for setting up a Bio-tech Park at Savli, Vadodara, India, 2002-03
▪ Member – American Association for the Advancement of Science, 1997
▪ Member – Research Advisory Committee of Biotechnology Division of National Dairy Development Board, 2002-2006
▪ Expert Nominee – Committee for the Purpose of Control and Supervision on experiments on Animals (CPCSEA), Ministry of Environment & Forests, Govt of India, 2003-04
▪ Member – Draft Biotech Policy Document of Gujarat, 2004-2005
▪ Member – Standing Committee on Animal Health (Mastitis) of the International Dairy Federation, 2004-2006
▪ Core Member – Institutional Biosafety Committee (IBSC), Intas Biopharmaceuticals Ltd., Ahmedabad, 2008-2010
▪ Member, Expert – Boards of Studies, M.S. University of Baroda, Vadodara, 2005-2011.
Publications / Patents / P
13 peer-reviewed publications in international and national journals.
▪ 1 book chapter published internationally.
▪ 1 editor, proceedings of an International workshop.
▪ 3 international patent applications filed (two granted)