Associate Director, Methods Development
Michael J. Hantman, PhD, is the Associate Director of Methods Development for Charles River Laboratories at its Malvern, PA. site. Over the past 16 years, Michael and his team have developed a portfolio of over 100 assays and methods used for the detection and quantitation of adventitious agents in biopharmaceuticals as well as for characterization of cell substrates used in the production of biopharmaceuticals. These methods focus primarily on nucleic acid amplification technologies (NAT)-based assays. They have been responsible for over 40 new assay validations and qualifications in the last five years, including specific and broad-range quantitative, fluorescent PCR assays for adventitious agents, residual DNA assays, copy number assays and nucleic acid sequencing projects.