AGC Biologics, a contract development and manufacturing organization (CDMO), with several decades of R&D experience in the monoclonal antibody (mAb) space, announced a new tie-up with GORE. The combined offering is aimed at allowing biopharmaceutical companies improve their downstream purification, and increase product yields in the R&D stages, ultimately leading to lower costs in the clinical manufacturing stages.
The collaboration includes the family of GORE protein capture devices with Protein A, which is designed to improve productivity in Protein A affinity purification and is said to provide high binding capacity at short residence times, alongside AGC Biologics’ mAb-based CDMO services.
Addressing developments in mAb market
Kasper Møller, CTO, AGC Biologics said investments in new technologies are important to meet its clients’ needs and address the changes in the mAb market.
The joint offering is available across various sites in the AGC Biologics’ network.
Process slowdowns and bottlenecks
William Barrett, product specialist, at Maryland, US headquartered, GORE PharmBIO, said the alliance can support antibody-based therapies coming to market by addressing bottlenecks and boosting productivity, enabling pharma players to reach their next clinical or commercial milestones.
Over the years, higher titers and other upstream process improvements have meant that Protein A columns could be over-sized and underutilized to gain flow and speed. Consequently, affinity purification is often the cause of process slowdowns and bottlenecks because traditional resin-based chromatography technology has not kept pace, according to Gore.
Its portfolio of Protein Capture Devices with Protein A, which uses an expanded polytetrafluoroethylene (ePTFE) membrane composite, optimizes Protein A use by maximizing binding capacity at high flow rates and low pressure drop, it said.
The increased productivity of the Protein A step, enabling a full single-use downstream process, can eliminate column bioburden from storage, reduce manufacturing footprint, and help lower costs for clinical manufacturing and select scale commercial manufacturing, said the collaborators.