Biotechnology, Bioprocess and Analytical Development, Process and Analytical Liquid Chromatography Development, Contract Manufacturing Oversight, Protein and Monoclonal Antibody Characterization for Regulatory Submission, CMC documentation, Regulatory compliance for GMP

Dr. Wilkins has spent his 40+ year scientific career in both industry and academics focused on biomolecules. As Vice President of Process Sciences and Manufacturing at Alexion Pharmaceuticals, he hired and led the development of these groups during the early development of the company followed by overseeing the assembly and equipping of Alexion’s first manufacturing facility. In addition to the above, Wilkins was co-author of several of the central patents underlying the intellectual property associated with its first successful drug. Following his time at Alexion, Wilkins joined the Yale University laboratory of Professor Csaba Horvath, a pioneer in the area of high-performance liquid chromatography (HPLC), a technique that has come to dominate the field of bioseparations and thus a key technology in the analysis of all biotherapeutic molecules. The collaboration resulted in several important contributions to the analysis of monoclonal antibodies (MAb’s). Jim was later invited to rejoin the Process group at Genentech (where he was a Scientist early in his career). Among other activities, he acted as an in-house consultant at a major contract manufacturing site for Rituxan and led the CMC team responsible for oversight of Phase 3 manufacturing of Ocrevus, a humanized, second-generation MAb product designed to complement and expand markets addressed by Rituxan. In addition, he and his group discovered that the latter antibody had the unique property of crystallization, a trait not normally associated with molecules of its size.  This work was the subject of a patent disclosure and subsequent filing. More recently, Jim returned to academia at UCSF where he studied monoclonal antibody structure and modifications using high-resolution separation and analytical technologies. Contact Jim.