We work with most cell lines used for manufacturing monoclonal antibodies and recombinant proteins, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines.
We have also worked with several different selection systems such as dhfr / methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience includes attached or surface dependent as well as suspension culture types.
Our Leadership Experience is Exceeded only by our Commitment to your Business
GBI's senior operational and quality staff have decades of experience in GMP manufacturing, which includes work at several leading biopharmaceutical companies. Therefore, our clients have the assurance of knowing that the individuals entrusted with the manufacture of their products are seasoned industry professionals with excellent track records. However, we donít stop there. Our goal is to provide excellent service that not only meets, but exceeds our clientís expectations.
Bansi has over 30 years of experience managing the growth of technological start up organizations to multinational Fortune 500 companies, including one that focused on the agricultural and biomedical industries as well as an OTC pharmaceutical company and a diagnostics laboratory. He brings a strategic vision and high level of experience in near- and long-term strategic business planning and improving operations as well as guiding companies through venture financing. Bansi earned a bachelor's degree in business at Delhi University and an MBA from the University of Maryland.
Muctarr Sesay, PhD Vice President of Process Development
Dr. Sesay has over 20 years of industrial experience in bioconjugation and modification of biological molecules (including monoclonal and polyclonal antibodies, enzymes, toxins and others) and small molecules and over 15 years of experience in the biotechnology sectors. Prior to joining GBI in 2002, Muctarr supervised many projects in R&D, Process Development and Manufacturing of biologics at Life Technologies (now Invitrogen), Kirkegaard and Perry Laboratories (KPL) and Elusys Therapeutics. Muctarr, after receiving his Ph.D in Biochemistry from the University of London, England worked for 3 years as a postdoctoral candidate at the University of Maryland, College Park in Protein Purification and characterization. In addition to his responsibilities at GBI, Dr. Sesay also is a member of the Advisory Committee for the Professional Science Masters Degree in Medical Biotechnology offered by the College of Health Sciences at Barry University.
With over 17 years of experience in managing Quality Assurance and Quality Control departments, Prema has leveraged a solid scientific background with technical experience in biochemistry, microbiology and chemistry, working on all aspects of early-stage drug development, including analytical method development and validation as well as establishing product specifications. She has a deep understanding of USP and EP methodologies which enables her to provide guidance and oversight for the release and testing of API, finished product and raw materials while assuring quality systems and standard operating procedures are in compliance with even the most stringent of requirements-- cGMP regulations. She also assists with IND submissions and in preparing CMC sections of regulatory submission documents. Prema attended the University of Madras where she earned a Masterís degree in Biochemistry and an undergraduate degree in Chemistry, and has published several research papers in reputable, peer-reviewed biological journals.
Amita Quadros, PhD, CCRC Director of Client Services
Dr. Quadros is well versed as a client advocate at GBI having worked for over 15 years in pre-clinical research and Phase I-III / BE clinical trials in a variety of therapeutic indications such as Alzheimer's disease, cancer, cardiovascular disease, hypertension and diabetes. Her attention to detail and management skills were honed by supervising over 30 employees, and she has authored and co-authored in over 20 peer reviewed articles and presented her work via various poster and platform presentations at international conferences. In addition, Dr. Quadros was the lead author in a chapter of a seminal text in COX-2 Inhibitor Research, and is an editor and reviewer for Scientific Journals International (SJI). In addition to her full time position as Project Manager at GBI, Dr. Quadros contributes her scientific knowledge as a Professor of Biology at Broward College. She completed her undergraduate work in Biochemistry at the University of Bombay and received her Ph.D. at Florida International University.
David Cunningham Director of Marketing & Administration
Dave Cunningham brings over 25 years of sales, marketing and supplier experience in Pharma and Biopharma as well as the diagnostic industry with multinational Fortune 500 organizations such as Akzo-Nobel, Beckman Coulter, Bristol-Myers Squibb, DuPont, Johnson & Johnson, Lederle Laboratories, Nitto Denko, Smith Kline Beecham, and Siemens, as well as numerous entrepreneurial and start up organizations. His extensive scientific background has also enabled him to contribute to the R&D efforts in monoclonal antibody and tetramer research, photodynamic therapy, as well as the development of oncolytics and immunotherapies. Dave completed his undergraduate work in Health Sciences from Slippery Rock University and received a Master of Arts degree in Public Service from Nova University.