A. Satish Menon, Ph.D.
Associate Director and Member
Office: 264 Batcheller
Phone: 701.231.5267
Satish.Menon@ndsu.edu
Satish Menon joined the Center for Biopharmaceutical Research and Production in 2010.
Menon has over 20 years of experience in establishing the technical infrastructure necessary for process development and developing commercial, early stage basic research and target drug validation in the biotechnology and pharmaceutical industries. His management experience extends over several functional areas including cell line development, cell culture, protein purification, molecular biology, analytical methods and process sciences.
Research and Technical Expertise
• Development of renaturation and purification protocols for cytokines and antibodies used in preclinical and clinical work;
• Protein chemistry including modification, characterization and analysis of recombinant antibodies and proteins;
• Multiple protein purification systems; designed and developed a disposable fluid chromatography system for purification of proteins;
• Development of immunoassays, such as ELISA’s, Western Blots for characterization, detection and analysis of protein bio-therapeutics;
• Analytical method development for characterizing recombinant therapeutics, such as HPLC based methods, IEF, 2D gel electrophoresis, SDS PAGE;
• Development of mammalian cell lines for the production of recombinant proteins and antibodies; experience with multiple cell lines including CHO, CHO RP-Shift, BW, NS0, NS1, S/P20, 293 and hybridoma cell lines; extensive experience with cell line selection, amplification and stabilization strategies;
• Media development for mammalian CHO cells, hybridoma and myeloma cells;
• Regulatory and quality requirements for media used in the production of human therapeutics.
• Development of Biosimilars, including knowledge and understandin of process, AMD, quality and regulatory issues;
• Writing scientific protocols and reports to support process validation and regulatory aspects;
• Project management in process development for novel therapeutics and for developing improved and modern processes for commercial product; developing new therapeutic entities and moving them from research to development to commercial manufacturing;
• Writing regulatory documents SOP’s and protocols and CMC sections of IND’s for biological; evaluating processes for regulatory and quality compliance according to the FDA and EMEA regulations;
• Evaluating CMO’s and CRO’s for contract manufacturing work and analytical method development.
Education
Postdoctoral Physiology and Biophysics, Harvard Medical School
Ph.D. Biochemistry, Indian Institute of Science, Bangalore, India
M.S. Microbiology & Biochemistry, G.B. Pant University, Nainital, India
B.S. (Honors) Microbiology, Pune University
Professional Positions
Associate Director and Member (2010 – present)
North Dakota State University, Center for Biopharmaceutical Research and Production
Principal Consultant (2007 – present)
Menon Consulting; A Process Sciences Consulting Company
Director, Biopharmaceutical Operations - Purification (2005 – 2007)
Allergan, Inc., Irvine, CA
Director, Process Development (2002 – 2005)
Genitope Corporation, Redwood City, CA
Research Fellow, Antibody Technology Division (2001 – 2002)
Senior Staff Scientist, Recombinant Proteins (1997 – 2001)
Staff Scientist, Recombinant Proteins (1991 – 1997)
DNAX Research Institute, Palo Alto, CA
Associate Principal Scientist (1991)
Senior Scientist (1989 – 1991)
Schering Plough Corporation, Kenilworth, NJ
