April 29, 2016 Rentschler Presentations at the BPI West 2016 in Oakland, CA
The annual BPI West meeting is focusing on bioprocessing issues from the discovery phase, through to the early and late stage process development to the commercial manufacturing. This year’s conference was held from 14 to 17 March 2016 in Oakland, CA, USA. Rentschler was represented by Dr. Dethardt Müller, Senior Director Process Science. He held two lectures on early stage decision points in product respective process development of recombinant proteins.
The first presentation “TurboCell™ - Leveraging lead candidate selection with homogeneous clone pools”, highlighted the current status of Rentschler’s proprietary platform for candidate screening and cell line development. Several case studies demonstrated the comparability of characteristics of the TurboCellTM pool and clone material. In all cases, the pool variance is significantly reduced compared to pools based on a classical approach. Additionally, a scalable TurboCell™ upstream process platform with optimized medium has been established. On this platform different antibodies demonstrate similar performance. Stable IgG expression levels up to 3 g/L could be achieved.
The second lecture “The single-use vs. stainless steel decision process - A CDMO perspective”, focused on the decision process regarding whether and when to use single-use devices or stainless steel equipment for biopharmaceutical manufacturing. Implementing single-use systems reduces capital costs, but in some cases capital savings are offset by increased operating costs. As basis for the decision a comparative cost of goods analysis for commercial campaigns in 2,000 L single-use and 3,000 L stainless steel bioreactors was presented. Additionally, diverse safety aspects, e.g. regarding extractables and leachables, was included. The results show that the decision-making is ambiguous. None of the arguments in terms of safety, cost-effectiveness, or operational efficiency is fully convincing to choose one technology platform or the other. For the selection of the appropriate variant for the specific situation a decision tree was proposed. It takes into account the verification of feasibilities, the assessment of risks and the consideration of future strategies.
Rentschler Biopharma SE
Dr. Cora Kaiser
Senior Director Corporate Communication