September 4, 2015 The Seventh Annual Bioprocessing Summit in Boston from 3rd to 7th August 2015

Rentschler presented expertise with process platforms and modular configured processes to express and purify therapeutic Proteins

From 3rd to 7th August 2015 Rentschler attended The Seventh Annual Bioprocessing Summit in Boston, organized by Cambridge Healthtech Institute. The Summit brought together record-breaking 850+ attendees from 29 countries. Participants came from academia and biopharmaceutical industry and met for 5 days of inspiring presentations and discussions about practical solutions for today's bioprocess challenges.

The meeting included five streams from “Cell Culture & Cell Line Development” over “Formulation & Downstream Processing”, “Analytical & Quality” to “Process Innovations & Cell Therapeutics” and “Regulatory & Risk Management”. Main topics of the event were suitable bioreactors scales and fully disposable USP/DSP systems, continuous processing, high-concentration protein formulations, early analytical development for biotherapeutics and cell therapy bioproduction.

Rentschler was represented by Dr. Stefan Schmidt, Vice President Process Science and Production. Schmidt held various functions such as Chairperson and Top Level Panelist and presented in two lectures Rentschler's broad expertise with antibody-like and non-antibody molecules.

Schmidt’s first presentation under the heading “Fc fusion vs. mABs, opportunities and limits of platform processes” has been followed by more than 200 participants of the Cell Culture & Cell Line Development stream. Schmidt pointed out that in theory, Fc-fusion proteins should behave quite comparably to mABs, both in upstream and downstream processes. However, in practice some differences can be observed. Well-established platform processes only partially match the requirements for Fc-fusion proteins. Typically lower expression levels and an increased tendency to aggregate are to be observed. Based upon this Schmidt discussed the range of manufacturing options for fusion proteins with regard to platform processes, modular concepts, and fully customized solutions in comparison to conventional antibody production. He demonstrated the suitability of platform processes for Fc fusions when taking some following considerations into account. These includes the selection of cell lines with high productivity and viability, the determination of appropriate capacity, contact time and elution for capture step, the elucidation of size and shape limitations and the identification of sensitive parameters for FcF stability. Otherwise, the other options are available.

In the Formulation and Downstream Processing Stream Schmidt presented in a second lecture Rentschler’s experience with various complex, difficult to express proteins. These molecules represent an increasing amount of therapeutic proteins. He demonstrated how to develop modular processes based on DOE principles mastering typical challenges as controlling glycosylation, increasing yields and suppressing aggregation. In various case studies he highlighted successful process design based on a differentiated modular DSP approach, optimization possibilities by using generic buffers and solutions for HCP and aggregation issues.