The Waltham, Massachusetts-based Protein A resin and bioprocessing tech supplier announced it has added a single-use format of its XCell Alternating Tangential Flow (ATF) platform to its portfolio at Biotech Week Boston last week.
Used to increase the efficiency of the upstream process, the tech increases cell density by up to three times and extends cell viability, according to Repligen spokesperson Sondra Newman.
“The single-use version dramatically improves ease of use and performs at the same high level as the stainless steel format, but with much faster implementation time,” she told Biopharma-Reporter.
It has also been developed for the same applications, centred mostly on mammalian cell culture for the production of recombinant proteins or viruses, using cell lines like CHO, MDCK, HEK293 and Vero.
“The technology can also be used in cell therapy applications, for example for the culture of stem cells, and in microbial cell culture applications, for the culture of E. coli.”
Repligen added the ATF technology in June 2014 through the $20.5m acquisition of the bioprocessing assets of Refine Technology.
At the time, the firm described the platform as “the gold standard” of cell retention technology, and announced it would look into developing a single-use product line.
Reduced costs
But much like other single-use technologies, the initial purchase cost of the ATF platform is significantly lower than the steel version.
“Implementation costs for a new user of XCell ATF 6 Single-use are about 55% lower than for stainless steel. Implementation costs for a new user of XCell ATF 2 Single-use are roughly 25% lower than for stainless steel,” said Newman.
“In addition, XCell ATF Single-use offers a dramatic savings in time and labor required for set-up and breakdown as compared to the stainless steel system. All activities related to autoclaving for sterility, including autoclave cycle development and validation, are removed from the workflow when single-use is implemented. Up to an 80% improvement in set-up labor hours can be realised.”
However, she continued, the cost of ownership depends on the size of the XCell ATF system and the number of runs executed.
“The single-use system has a higher number of consumable components as compared to stainless steel, but the cost is offset by the resource savings.”
Downstream feature
During the show, Repligen also introduced a new resin recovery feature on its 45 cm and 60 cm Opus(R) pre-packed chromatography columns.
The feature “allows extraction of chromatography resin from Opus(R) for re-use, in the event of an operator error or a manufacturing deviation,” Newman explained.
“A customer may also wish to recover resin at the end of a campaign, in which case ‘lightly used’ resin could be repurposed in process development or pilot studies.”
This could lead to significant cost savings, she added, especially when recovering Protein A resins. Protein A is used to capture monoclonal antibodies and can account for up to 30% of the cost of making such drugs.