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Diabetes & Endocrinology Experts

Bhagyesh Kulkarni

Executive Officer at Serum Institute of India Limi
Medicine
Serial Com?rcio de?Equipamentos e Ferramentas Ltda
India

Biography

Executive Officer Company Name Serum Institute of India Limited Dates Employed Sep 2007 – Present Employment Duration 10 yrs 1 mo Location Pune Area, India Executive Officer – Hib PRP bulk manufacturing project (2010 – Till date) Manufacturing PRP bulk for pentavalent vaccine project. Profile includes planning of production activities. Commercial product and facility related documentation. QC and IPQC result data management. Designing developmental experiments. Officer – Hib PRP bulk Development Project (2009 – 2010) Part of WHO approved facility set up team. Equipment qualification and related documentations. SOP and BMR preparations. Successful engineering lots. Successful consistency lots. Officer – Poly Sialic Acid Department and CRM-197 Project (2007 – 2009) Project: Polysialic acid (PSA, a polysaccharide molecule) Scale-up development of PSA. Commercial manufacturing of monodispersed and oxidized PSA. Commercial product and facility related documentation. Project: Cross reacting molecule (CRM197, a recombinant protein molecule) Designing developmental experiments. Successful pilot scale purification. Developmental product related documentation.

Research Interest

Pharmaceutical company

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