Our Team
Crown Point Biotech Consulting
Partner
Crown Point Biotech Consulting is runned by Steven M. Erb, Ph.D.
Steve has over 13 years of industry experience in CMC product development specializing in analytical. development and strategy, quality control, and CMC regulatory affairs at small biotech and big pharma companies with focus on cell therapy and virus vaccines. He has expertise in in-process, release and characterization method development, method qualification, control strategies, quality control. product comparability, tech transfer, stability authoring IND/IMPD/DMF/briefing documents, and external vendor management. Steve is the owner and principal consultant for Crown Point Biotech Consulting LLC where he supports client CMC needs.
Prior to starting Crown Point Biotech Consulting, as Associate Director AD &QC Steve led NK cell therapy product analytical development and QC activities for Sanofi and Kiadis Pharma (acquired by Sanoft) at multiple CDMOs. He implemented the outsourcing strategy for development and qualification of analytical methads, performed due diligence for CDMO selection, and tech transferred the entire NK cell analytical paradigm to external partners. He led the Quality Control program at CDMOs for disposition of product for clinical trials and was the internal Analytical Team Leader for a gene edited NK cell therapy program bringing the product analytics from pre-clinical to IND phase. Steve also strategized and designed complex drug product authored multiple Module 3 IND and briefing book sections supporting the program.
As part of CBR International, a regulatory consuhancy. Steve was the pamar, author and reviewer of CMC Module 3 sections for multiple IND and IMPD submissions and provided guidance on regulatory strategy for diverse biologies products.
Steve began his industry career as a scientist working for Takeda Vaccine Inc, and yagen Ire. (acquired by Takeda) on a live attenuated tetravalent dengue virus vaccine that has since been commercially released. He was project lead fior multiple areas of vaccine developmert in the CMC organization including analytical method development for cel-based potency assays and formulation development where he is co-inventor on patents in both areas. He managed and executed the drug product stabilty program and was the program lead and process owner for yophilization development of the tetravalent vaccine. Steve abtained his Ph.D. in virology at Colorado State Unversity.