About Nadine M. Ritter, Ph.D.
President and Senior Analytical Advisor
Mobile Phone: +1-240-372-4898
Nadine M. Ritter, Ph.D., obtained her master's and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 years.
Dr. Ritter entered the biopharma industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer, and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for in vitro diagnostic product submissions, responded to FDA comments, contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of an R&D analytical lab.
Dr. Ritter then became the Director of the Analytical Services Division of BioReliance (Rockville, MD), a major contract testing organization. There, she led a team of CMC scientists in the design and conduct of method qualification, validation, and transfer, product characterization and comparability studies, and QC release and stability testing. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles. She managed quality and compliance activities for the R&D, GLP and GMP activities conducted in her lab, and implemented Part 11 computer system requirements.
In 1999, she created the first public training class specifically focused on biological product stability programs, which later grew into an award-winning CMC analytical training course. She conducts in-depth training workshops of all aspects of CMC analytics for biologically-derived products, updating class materials and reference documents each month.
Since 2002, Dr. Ritter has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently as NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA).
In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. Through Global Biotech Experts, she can bring in affiliate support from elite consulting colleagues with extensive experience in process development and validation, manufacturing facility PAI and GMP inspections, and technical writing for R&D and GMP applications.
Throughout her career, Dr. Ritter has contributed to the success of over 120 international IND/IMPD and BLA/MAA filings and Post-Approval Change Protocols. She has engaged in numerous PAI readiness audits and due diligence inspections and has remediated analytical, regulatory and laboratory compliance problems around the world. She is on the CMC scientific advisory boards of several international biopharmaceutial companies.
In 2003, she was one of the co-founders of the CaSSS CMC Strategy Forum, which has led to the publication of major industry/regulatory white papers on CMC topics and is now being held annually in North America, Europe, Japan and Latin America. She is a past member of the PDA BioAB, and is the current President of the Board of Directors of CASSS.
Nadine M. Ritter, Ph.D. - Full CV
Nadine M. Ritter, Ph.D.