The talk will cover using a strategic approach in leveraging process development planning and facility fit (Monte Carlo analysis) to design a flexible commercial manufacturing end-to-end single use facility to produce 10 KG of BDS per batch. Additionally, the presentation will discuss starting up the drug substance manufacturing facility with support systems (buffer preparation, WFI generation/ distribution system) in an expedited fashion to minimize manufacturing down time.
Dr. Carnley Norman is the Vice President of Manufacturing Operations at the KBI Biopharma Durham Mammalian Cell Culture Manufacturing site. Dr. Carnley has over 18 years of therapeutic protein drug substance and vaccine process development, characterization, technology transfer and manufacturing experience with KBI Biopharma, Novartis, Astra Zeneca (MedImmune), Amgen and Merck. Prior to joining KBI in 2014, he led and managed the Manufacturing Science and Technology (MS&T) purification groups at Novartis Vaccines (Lab and MFG Support groups) focusing on process validation, technology transfer, manufacturing support process optimization/improvement in support of flu cell culture manufacturing. He also represented MS&T on the Flu Cell Culture Bulk Operation Leadership Team. During his career, Carnley held technical leadership roles for 9 new product introductions to commercial manufacturing sites including 4 new drug substance facility start-up projects. Two of these projects won ISPE Facility of the Year Awards. He also led process modeling initiatives at Amgen, MedImmune and Novartis. This includes facility simulation, fit-to-plant related modeling and equipment modeling using computational fluid dynamics (CFD). Carnley received his Ph.D. in Chemical Engineering from North Carolina State University with a Minor in Business Management (concentration in Technology Transfer).