PME 570:Biopharmaceuticals - Product Development and Upstream Production Systems
Course covers the following topics: Structure and physical, chemical and biological attributes of biologics. Product stability, pharmacokinetics, delivery. Critical quality attributes of Pioneer Drugs and Biogenerics. Fundamentals of nucleic acid and protein structure and function. Genetic engineering tools. Modern production vectors and hosts. Cell line and media selection and optimization. Cell-bank characterization and stability. Upstream processes. Culture, fermentation and scale-up. Critical upstream process parameters, regulatory controls and validation. Rapid vaccine manufacturing and monoclonal antibody case studies. Prerequisites: Students must have taken at least one course in organic chemistry and one course in biochemistry, molecular biology, or genetics, or equivalent background as determined by instructor.
Schaefer School of Engineering & Science
Department:
Mechanical Engineering
Program:
Pharmaceutical Manufacturing Engineering
Dr. Nikos Panayotatos is an Independent Expert in Biotechnology with over 30 years of academic, industrial, consulting and teaching experience in R&D of biologics and intellectual property.
Dr. Panayotatos received degrees from the University of Athens (B.Sc.), Ohio University (M.Sc.) and Loyola University of Chicago (Ph.D.), and conducted post-doctoral work at the University of Wisconsin. In his academic research, he discovered, among others, the T7 late promoter and cruciform DNA structures in vitro and in vivo.
He subsequently joined the biopharmaceutical industry and held senior positions at Biogen S.A. (now Biogen Idec), Michigan Biotechnology Institute/Michigan State University and Regeneron Pharmaceuticals, where he planned and directed the development of many human recombinant proteins as therapeutics. As part of his work, he invented gene expression systems, protein production technology, rationally designed proteins and targeted drug delivery methods. For the last 14 years, Dr. Panayotatos has been advising clients on the development of recombinant proteins, including mAbs and small peptides, as well as on technology and intellectual property assessment. As part of this work, he has planned, directed and testified on experiments testing patent validity and infringement, and provided technical expertise on major cases of patent litigation that won settlements of over $600 million.
Since 2008, Dr. Panayotatos has also served as Professor (Adjunct) in the Pharmaceutical Manufacturing Engineering program at Stevens Institute of Technology, where he has taught two courses (PME 530 and PME539); he is currently developing a new course, PME570, focused of upstream process development of biologics manufacturing. Dr. Panayotatos’ research is described in 42 major publications, 17 US patents and many patents worldwide. He speaks English, Greek and French.
Research & Education
Education
Dr. Panayotatos has received degrees from the University of Athens (B.Sc.), Ohio University (M.Sc.) and Loyola University of Chicago (Ph.D.) and conducted post-doctoral work at the University of Wisconsin.
Experience & Service
General Information
Dr. Nikos Panayotatos has over 30 years of academic, industrial and consulting experience in R&D of biologics. His work is described in 43 major publications, 17 US patents and many patents worldwide. He speaks English, Greek and French.
Experience
He has held senior positions at Biogen, Michigan Biotechnology Institute/Michigan State University and Regeneron Pharmaceuticals. Dr. Panayotatos has planned and directed the development of many human recombinant proteins as therapeutics. He has invented gene expression systems, protein production technology, rationally designed proteins and targeted drug delivery methods. He has discovered the T7 late promoter, cruciform DNA structures in vitro and in vivo and created hybrid enzymes targeting unusual DNA structures. As a consultant, Dr. Panayotatos has advised clients on the development of recombinant proteins, including mAbs and small peptides; led the efforts of a start-up company as interim CSO; provided technical expertise on major cases of patent litigation that won his clients settlements of over $600 million; and, advised clients on technology and intellectual property assessment.
