R&D Study reveals the promise of downstream technology capable of harvesting volumes of 2,000 L at titers ranging up to 10 g/L purification.
Today, we announced a new research paper from its global research and development Center (R&D Center) titled, Building a Fully Single-Use Process: High Productivity Protein A Membrane Devices that Complement Disposable Upstream Technology. In the research, our scientists share exclusive data on the promise of new single-use devices that alleviate common monoclonal antibody (mAb) purification problems that can occur when using standard Protein A resin columns.
The new research is available immediately and offers biopharma developers a glimpse into the promise of single-use technology for the Protein A membrane capture chromatography step, using the GORE® Protein Capture Devices with Protein A as a technology use case. The paper also features conclusions on the benefits of this innovative technology, such as reduced manufacturing footprint, reduction in lead-time and consumable costs, and more.
There are several important topics covered in the study, including:
- Overview of protein A capture technology: A recap of the promise offered by single-use membrane chromatography technologies; including their ability to operate with a high flow rate and achieve high productivity and disposable process; featured performance data on manufacturing scales of Protein A membrane devices, including small scale and manufacturing scale comparisons.
- Benefits single-use devices offer to the manufacturing process: When paired with single-use bioreactor upstream strategies, the research found contamination risk, operation time relating to preparation and cleaning, and operator error were all reduced. The technology also offers cost savings, reduced risk, lower bioburden, greater speed to market, and other benefits.
- Purification productivity data: single-use devices vs. standard resin: Protein A membrane devices showed 10 times higher productivity than the Protein A resin column on the purification of mAb cultures. Other data includes productivity details, including removal of host cell proteins (HCP) and host cell DNA, when compared with resin columns, reduction in bioburden, time savings, and more.
- R&D review: implementing protein A membrane device into traditional manufacturing flows: A review of the implementation process for these devices and how they can be implemented for all vessels and into existing flow-paths, the ion exchange membrane device, and single-use TFF membrane capsules, while improving efficiencies to purify mAb in a short process time.
The AGC Biologics R&D Center focuses on modernizing and advancing processes and technologies used for biopharmaceutical development and manufacturing capabilities. The scientists within the team are responsible for developing and implementing new procedures and evaluating innovations that help developers of protein biologics and advanced therapies improve titers/yields, cell line development, downstream purification analytical analysis, and more.
