Bioprocessing Breakthroughs and Solutions that Work

An initial case study examining the effects of pre-transfection perfusion on AAV2 viral vector production rates will be presented. Initial studies indicate the exchange of vital nutrients prior to transfection maintain cells in a more optimal state of exponential growth during transfection, which leads to higher viral production.

In response to customers challenged with bioburden-sensitive TFF processes, technology leading single-use TangenX™ TFF Flat Sheet Cassettes are now available in closed and irradiated format. Used in ultrafiltration and diafiltration, the new cassettes come pre-assembled and pre-tested, using the same proprietary membrane choices and multiple MWCOs as SIUS™ Flat Sheet Cassettes. This session will demonstrate how the new cassettes integrate easily into any process with faster turnaround time, improved productivity and lower risk of contamination.

This presentation is an exploration of method development, manufacturing implementation, and facilitating global adoption while highlighting lessons learned and best practices for a robust migration to SoloVPE®. Additionally, we will also look into compelling novel applications of SoloVPE® and FlowVPE® technology beyond concentration determination.

High Productivity Harvest (HPH) is a novel application developed by Repligen that enables you to harvest a fed batch bioreactor in a fully sterile manner while eliminating both centrifugation and depth filtration. A 0.2 µm filtered, closed system and single step process using the XCell™ ATF System, HPH can significantly increase yields above industry standards and generate a sterile clarified batch harvest ready for either batch or continuous chromatography. This presentation will demonstrate how HPH works, present initial results of up to a 2-fold increase in protein production, and how you can apply HPH specific to your product need or facility design.

As a bioprocessing innovator with technology expertise in filtration, Repligen has developed a breakthrough clarification and harvest technology that can signal a paradigm shift in mAbs bioprocessing. A result of continuous innovation at Repligen, the solution integrates advances in multiple disciplines, combining novel polymer technology, various filtration modes, hardware, systems and automated process management. Potential benefits to productivity, product quality, yield and workflow efficiency will be discussed.

The 2000 L Single-Use Team needs a fully closed and single-use harvest solution for 500 L - 2000 L volumes for the new end-to-end single-use Clinical Supply Center build-out in Genentech South San Francisco to enable cost effective, flexible, faster technology transfer to different sites, and faster biopharmaceutical manufacturing. Traditional batch harvest historically has been performed with centrifugation and/or depth filtration to remove cell mass and further particle removal. Towards a fully closed and single-use harvest process method, the team collaborated with the vendor to develop Tangential Flow Depth Filtration (TFDF™), which was at its Beta testing stage in the first quarter of 2018. The effort focused on understanding the technology and establishing optimal filter properties for harvesting different molecules. Three different filtration scales were assessed. CCF and permeate were analyzed for titer, yield, turbidity, lysis, product quality and impurities at the conclusion of each run. Identification of key filter properties, challenges encountered during evaluation, harvest performance data, and implementation plan will be discussed.

Avid BioServices commissioned a new commercial facility that exploits single-use and disposable technologies. As part of this plan, Avid implemented the use of Repligen OPUS® Pre-packed Columns in a multi-column process. Their use has led to reduced set-up time, reduced process time, reduced capital and validation expense. This case study will describe the new facility and provide data demonstrating the positive impact of pre-packed columns in a multi-product manufacturing facility.

Praesto® Jetted A50, a novel protein A agarose resin, has emerged as a contender to current and next-generation mAb capture technologies. This resin leverages a proprietary jetting-based bead manufacturing process enabling claims of improved bead uniformity with a very narrow particle size distribution, while delivering ultra-high binding capacity and alkaline stability. At Biogen, several studies using this new type of resin have been conducted to evaluate cost savings and productivity gains. Batch capture mode, as well as process intensification approaches such as super batch and continuous capture were examined.