Dr Krishan Kumar Raina is B.Tech (First Division with Distinction) & Ph D in Biotechnology and Biochemical Engineering (CGPA 9.5/10) from Indian Institute of Technology (IIT) Delhi. He has over 40 years’ experience in Research, Process Development, Scaleup and GMP Manufacturing of Biopharmaceuticals and Biosimilars. He started his career as a Research Scientist with Vittal Mallya Scientific Research Foundation (VMSRF), UB Group Corporate Research Centre at Bangalore. The research work was in the area of Gene design, synthesis & cloning including protein expression and purification.

Dr Raina had his Post Doctoral fellowship research work at Leicester Biocentre UK, the research work titled “Cloning and Expression of Fusion Proteins (r-DNA derived) was submitted for US Patent and subsequently granted (US Patent 6,337, 194 B1). Later moved to leading pharmaceutical Organization Lupin Limited based at Mumbai to lead the research and manufacturing of anti TB drug Rifamycin. The facility was approved by US FDA. He joined as facility head and General Manager at Antibiotics and Microbial Products division of Ms Alembic Limited (WHO-GMP approved) at Vadodara for process development and manufacturing of fourth generation biopharmaceutical. Successfully introduced New Biopharmaceutical for domestic markets. He was Vice President and Site Head of Entire Biotech Park (API, Formulation and OSD) M/s Wockhardt Biotech Limited at Maharashtra.

The accomplishments’ included the successful technology transfers of all the insulins and insulin analogs (Microbial Expression) and Erythropoeitin (EPO) (mammalian Cell based) scaling up to commercial scale. Successfully obtained the market authorization (CDSCO) for these biosimilar products. Audits from ANVISA, INVIMA, US-FDA, COFEPRIS, GCC and many other health authorities were successfully completed. Awards for national and international SAFETY for recognition of Organizations safety first and compliance always.

Post Three and half decades of biotech experience, extended my experience in GMP manufacturing of Biosimilars with M/s MJ BioPharma (House of Insulins) at Poona and later with M/s Strides Biopharma at Bangalore as CMC lead for insulin Glargine. To continue the passion on new learnings, joined Symbiotech Pharmalabs Limited, Indore (House of Hormones and Steriods). The accomplishments was to develop Biotransformation reaction and successfully scale up to commercial scale.

Dr Raina is presently leading the GMP Manufacturing of Cell and Gene therapy with Medtherapy Biotechnology (I) Pvt Limited. The Mission is to be Global Leader in large scale manufacturing of both Viral vectors and CAR-T cell products at Quality (pharmacopeial), Cost (affordable) & Delivery (timeliness).