Biotechnology Innovation Services
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Satish Menon has many years of industrial experience in research, development, and management of protein-based therapeutics. He is an expert in the development of protein-based therapeutics such as cytokines, monoclonal antibodies, and toxins from research to therapeutic. He has had extensive experience in process development, commercial manufacturing and research in the upstream and downstream areas of protein therapeutics development.
Dr. Menon served for 14 years on the Staff at Schering Plough initially in the process development group in New Jersey, and later for 12 years at DNAX Research Institute in Palo Alto,
At DNAX, he set up and was the head of the recombinant protein laboratory and worked on the upstream and Downstream development of multiple novel cytokines and chemokines as well as the development of high throughput methods of protein production. Dr. Menon has experience with bacterial, insect, yeast and mammalian expression systems and purifying proteins manufactured using these systems. He also set up a facility for Monoclonal antibody production including upstream and downstream development and worked on the development of multiple antibodies.
As Director of Process development at Genitope Corporation, Dr. Menon established the process development group and worked on developing a manufacturing process using disposable production technologies for the clinical and commercial manufacturing of Genitope’s personalized therapeutic vaccine.
As Director of Bioprocess Development at Allergan, Dr. Menon worked on understanding and characterization of the commercial process for Botox. This understanding led to the development of a new and improved process for Botox at a considerably lower scale and cost.
Satish Menon has extensive experience in the development of manufacturing processes for therapeutics focusing on fermentation and purification and in the regulatory aspects of biotherapeutic development, in developing processes that meet current GMP standards. He has experience in writing documents for regulatory filings, protocols, reports and SOP’s and batch records and comparability protocols. Dr. Menon has experience in Analytical Method Development for biotherapeutics and has worked on methods for characterization and release of therapeutics.
Satish currently works as a consultant in process development on projects such as Bio-generics development, where he consulted on upstream and downstream issues; Development of single-use chromatography and TFF systems; Writing CMC sections for IND filings; Development of manufacturing processes, and Evaluation of quality and regulatory aspects of manufacturing processes; Development of infrastructure for production of protein research reagents and development of novel technologies for cell culture fermentation.