Biography

Dr. Peter Kalinka is Chairman and Principal Consultant at Longmore 60 Biotech Inc. He possesses in-depth knowledge of drug development and directed numerous development projects including Therapeutic Proteins, Monoclonal Antibodies and Fusion Proteins. His experience in overall development spans cloning, process development, scale up, (e-coli, CHO, Hybridoma etc.) analytical development, bioassays, pre-clinical, clinical Phases, to manufacturing and regulatory affairs. Working with more than 20 companies world-wide, Dr. Kalinka has directed all, or spearheaded parts of development programs for Biosimilars, Biobetters and Biologics. Peter is a pioneer in the biosimilars arena, responsible for the development of Omnitrope, the first biosimilar in the EU, Australia and the US. Thereafter in the development of the second biosimilar hGH, Valtropin. From 2006 Dr Kalinka set up, de-novo, a functional Biopharmaceuticals Division within Apotex, Canada. He developed a biosimilar G-CSF which was approved by the European commission in May 2014. In December of 2014, the FDA accepted the application for the first biosimilar of Amgens Neulasta, Peg G-CSF, under the 351(k) pathway. On April 5th 2018 the same Peg G-CSF was approved by Health Canada. The first Peg G Biosimilar to be approved in a highly regulated market! For nearly 5 years he supported a Brazilian Biotech consortium in establishing a footprint in development and manufacturing of Biosimilars and Biologics (eg second generation Mabs) for submission in highly regulated markets.

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Research Interest

Cloning Process development Scale up, (e-coli, CHO, Hybridoma etc.) Analytical development, Bioassays, Pre-clinical, clinical Phases, to manufacturing and Regulatory affairs.