Nigel Darby Advisor at GE Healthcare

How can process intensification help you manufacture biopharmaceuticals quicker and at lower cost? Let us count the ways.

There are many options for improving bioprocess productivity. These vary depending on the unit operations in your processing train. Here we will discuss possibilities across upstream and downstream. First, we will pinpoint factors to help you design a productive perfusion process. Media development, cell line productivity, and bioreactor design will be emphasized. Next, we will describe the process intensification toolbox for downstream processing. Choices include continuous mAb capture, new high-productivity chromatography resins, and capture on novel fiber-based chromatography devices. Other tools are in-line buffer conditioning and straight-through processing. Last, we will address end-to-end options that increase automation level, including ‘off-the-shelf’ factories. We hope you leave this talk with ideas for improving your biomanufacturing processes.

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.