Single-use bioprocessing systems in the upstream have been fully adopted by industry, but according to Ontario, Canada-based chromatography technology firm Natrix Separations in the downstream the current generation of disposable Protein A columns are not truly single-use.
“Commercially available single-use downstream systems do not yet offer the productivity levels required to enable a holisitic, fully-integrated downstream platform,” CEO John Chickosky told Biopharma-Reporter.
“Several single-use chromatography tools and systems have been adopted for specific applications, but even those have not fully penetrated the industry,” he continued, adding the current generation of disposable Protein A columns are not truly single-use.
“They still contain expensive resin that must be amortized over dozens of batches to be cost-effective. Each batch requires cleaning, quality review and monitoring of the resin.”
Sanofi & Merck
Natrix is developing what Chickosky said is a “truly single-use” membrane-based Protein A platform for antibody purification and is hoping to accelerate the programme through partnerships penned with Big Biopharma firms Sanofi and Merck & Co. (known as MSD outside North America).
“The partners are providing funding to support the programmes, and are also providing biologic material, technical feedback, and are verifying performance,” Chickosky told us. “The teams collaborate on testing and data analysis to formulate recommendations and conclusions.”
The platform uses Natrix’s sponge-like three-dimensional membranes, and every surface throughout the structure is densely comprised of binding sites, so the purification stream is constantly presented with binding opportunities.
Such technology allows a much higher antibody capture rate than essentially two-dimensional membranes being used in current systems, Chickosky explained.
“Resin columns are the current benchmark, especially for Protein A capture applications. Resins offer excellent binding capacity, but due to their small pore size, they rely on diffusion flow, which is inherently slow. In order to satisfy process requirements, resin columns need to be oversized, and quite often, the expensive media is underutilized.”
He added: “Natrix HD-A membranes combine the high capacity of resins with the fast flow rates of membranes. The result is a very small device that can be fully utilized and disposed of after each batch.”
In related news, Natrix announced yesterday it has struck a deal with Germany's Scil Proteins for the engineering and development of the proprietary Protein A ligand that will be integrated within its membrane technology.