A Masters in Biotechnology from Sri Venkateswara University, Tirupati, India, Mahesh Kumar has 21+ years of experience in downstream purification, assay development at R&D stage for recombinant therapeutic proteins and new chemical entities. He has also worked extensively in Quality control with a focus on environmental monitoring of production areas and QC release of water, raw and packing materials, and in-process sampling during biotherapeutics manufacturing.

Possessing a deep understanding of the product development life cycle of biosimilar molecules, he has successfully handled the movement of products from Preclinical to Phase I, right up to regulatory approvals. One of the products he handled was granted marketing authorization in 2014, by WHO, India.

Prior to Procell Biologics, he has worked in leading biopharma companies such as M.J. Biopharm (P) Ltd., Piramal Lifesciences Pvt. Ltd., Wockhardt Research Centre, and Shanta Biotechnics Pvt. Ltd. He has worked extensively in the Purification department at Shanta Biotech & Wockhardt Research Centre and has established a successful process for biotherapeutics at R&D scale. He has developed assays for screening of antidiabetic molecules for drug discovery lab. He is experienced in developing bioassays for antidiabetic molecules at Piramal Life Sciences.

In the Quality control department at M. J. BioPharm, he was responsible for cell bank maintenance and characterisation, method development, method validations, lot release, stability studies, impurity clearance, cleaning validations, process validation and product characterisation studies of therapeutic proteins of E. coli. products.

Some of his quality contributions led to the filing of Insulin Human for US-IND, WHO and EU approvals. He is experienced in Regulatory Audits for QC department for WHO, EU, MHRA, SAHPRA, Customer audits and Due diligence.