13:30 – 14:30 – David Valentine, Lonza
Disposables are Not Something to Throw Away (Why Single-Use Is Here to Stay!)
- How bioprocessing steps have been transformed by single-use over the last two decades.
- What has worked well, not so well, and how the assumed benefits of single-use have transpired in practice.
- What are the transient elements of a single-use plant, and what are the more permanent aspects to consider for consumable ware and hardware. How this enables a facility that is both flexible and future-proofed.
- How ‘universal’ control systems help standardize data capture and analysis systems and provide a future design blueprint that can be applied across the plant. A concept most easily implemented and sustained when component parts are single-use.
About David Valentine
David Valentine has 21 years of experience in mammalian cell culture process transfer and scale up at Lonza Biologics, and 24 years total pharmaceutical industry experience. Responsibilities have included: Managing pilot batch stages of contract manufacturing projects; process transfer activities bridging process development and cGMP operations; acting as a subject matter expert for cell culture operations; completing process validation studies leading to new product licence applications. In addition to contract manufacturing support, he is involved in global standardisation projects and evaluating new technologies. David has led the design and start-up of a number of bioreactor installation projects within Lonza. He has been engaged in many new technologies and their application to cGMP manufacturing, such as optimising Lonza’s platform processes in single-use stirred bioreactors, and the design and implementation of state of the art bioreactor control systems.