Keystone Bioanalytical is a Contract Research Organization (CRO) founded by a leading team of professionals from the US pharmaceutical and contract service industries, providing broad and integrated bioanalytical and metabolite identification services for pharmaceutical and biotechnology companies.
We are an FDA compliant GLP facility licensed for DEA substances. Our instrumentation includes state-of-the-art AB Sciex API 7500 triple quadrupole mass spectrometers as well as Thermo Fisher Q Exactive and AB SCIEX 6600 Triple TOF Spectrometers that are mainly employed for in vitro and in vivo drug metabolite profiling and identification.
We have an established infrastructure that includes SOPs, QA, IT and Archivist. Our staff includes registered Quality Assurance Professionals in Good Laboratory Practice.
Keystone Bioanalytical is an optimal outsourcing solution for bioanalytical services to support drug discovery, drug metabolism and pharmacokinetics, clinical bioavailability bioequivalence, and bioanalytic services.
Founder, Lab Director
Dr. Xu earned his Ph.D. in biochemistry from the University of Maryland. He has more than twenty years of experiences in the pharmaceutical contract services industry. Dr. Xu's work includes numerous projects that have led to NDA or ANDA approval.
Prior to forming Keystone Bioanalytical Dr. Xu was the Founder and President of Keystone Analytic Labs, acquired by SFBC International in 2001. He has also served as chairman of iPhase Pharma Service, and was Director of Mass Spec Lab, a division of Harris Lab (currently MDS Pharma).
Vincent Windisch, Ph.D.
Co-Founder, Associate Director
Dr. Windisch has more than 10 years owning and managing contract research organizations. After earning his Ph.D. in chemistry from the University of Pennsylvania, Dr. Windisch went on to work in Big Pharma where he had numerous publications and was awarded two patents while working for Glaxo-Smith-Kline, Aventis, and Baxter Healthcare.
Prior to Keystone Bioanalytical, Dr. Windisch helped create and guide the formation of Absorption Systems where he was co-owner and Vice President of the bioanalytical operations. Dr. Windisch also previously held the position of associate director at Pharmanet Development Group. Dr. Winidisch is a registered quality assurance professional.
John Simon, Ph.D.
Principle Investigator, Immunoassay and Biomarker
Dr. Simon has over 20 years experience in industry designing and manufacturing enzymes, antibodies, biochemical assays, and ELISA’s for use in academic, pharmaceutical, and government laboratories. Additionally, he has experience working in bioanalytical laboratories performing assays, data analysis, and report writing.
Dr. Simon received his Ph.D. in Biology from Carnegie-Mellon University in 1988. Subsequently, he did academic research at the University of North Carolina studying the protein biochemistry of actin cytoskeleton dynamics, microtubules/mitosis, and nerve growth cone signaling. His research results have been reported in several publications.
Mingshe Zhu, Ph.D.
Dr. Mingshe Zhu is a biotransformation scientist and has over 25 years of working experience in pharmaceutical companies and CROs. His work has supported regulatory approvals of Aripiprazole and Dapagliflozin worldwide and Anlotin, Ensartinib Hydrochloride, Fospropofol Disodium, Donafenib, Olverembatinib in China.
He and his collaborators at Bristol-Myers Squibb developed several innovative LC-MS workflows and data-mining technologies, including mass defect filter, background subtraction and multiple ion monitoring for drug metabolite profiling and identification.
Recently, his research interests have expanded to ADME strategies and methods of unconventional drug modalities, such as ADC, PDC, peptides, herbal medicines, covalent drugs, and stable isotope labeled drugs.
Dr. Zhu received Ph.D. in analytical toxicology at SUNY Albany and completed post-doctoral fellowship in drug metabolism at University of Washington. He taught drug metabolism and mass spectrometry short courses at ASMS, EAS and ACS. Dr. Zhu co-edited two books, Drug Metabolism in Drug Design and Development and Mass Spectrometry in Drug Metabolism and Disposition and co-authored over 100 research articles (https://pubmed.ncbi.nlm.nih.gov/?term=Mingshe+Zhu&sort=date&size=100).