ChromaTan has won a $2.5 million FDA contract to develop an integrated, continuous downstream purification platform for production of monoclonal antibodies (mAbs).
The two-year project will entail process development, design, and testing of the company’s column-free platform, called Continuous Countercurrent Tangential Chromatography (CCTC™). The multiunit operation process train is designed to continuously purify a mAb harvested from a Chinese hamster ovary (CHO) cell-based bioreactor system at steady state through multiple purification modalities.
ChromaTan said the platform is intended to advance the production of antibody therapies by “significantly” improving product quality and enabling more flexible manufacturing facilities and cost-of-goods reductions.
The company will carry out most of its platform development work at its new laboratory in Philadelphia’s University City Science Center. ChromaTan said it expects to announce available jobs related to CCTC in R&D management, process analytical technologies, and quality control.
“At this time, there is no doubt that continuous manufacturing is on its way to becoming a reality in bioprocessing. We believe we have a unique offering in our CCTC platform that will enable manufacturers to transform the way they produce these much-needed therapies,” ChromaTan founder and CEO Oleg Shinkazh said in a statement.
Speaking with GEN in 2015, Shinkazh called CCTC “a truly continuous operation” compared with multicolumn systems, which he said are only semicontinuous, since their effluent comes out in pulses: “Column chromatography is reaching its limits in throughput and capacity.”
ChromaTan in July trumpeted successful results for a CCTC collaboration involving researchers from Eli Lilly and Pennsylvania State University (PennState)—namely higher productivity, lower operational pressure, disposable flow path, and lower resin use compared with column chromatography.
In a study published in the Journal of Chromatography, the researchers reported that the platform showed up to 101 grams of mAb/L of resin/hour productivity, 10 times higher than in a batch column, as well as a 5% yield increase (95% with CCTC vs. 90% in batch column) after optimizing elution pH to a narrower range of pH 4–4.5.
A startup within PennState’s Innovation Park in State College, PA, ChromaTan is funded by individual investors, NIH SBIR grants, Pennsylvania state funds, Ben Franklin Technology Partners of Central PA, and Life Science Greenhouse of Central Pennsylvania.