Provider of continuous and single-use chromatography solutions for biotech, ChromaTan, has been awarded a $2.5 million contract from the US Food and Drug Administration (FDA) for development of a new continuous purification platform.
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The project is aimed at the development of an integrated, continuous downstream purification platform for production of monoclonal antibodies. Most of the work to be performed on the continuous countercurrent tangential chromatography (CCTC) platform will take place in the company’s new laboratory location in West Philadelphia.
“We are thrilled to begin execution of this contract,” said Oleg Shinkazh, ChromaTan’s founder and CEO. “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. We also look forward to working with the experienced team at the FDA to provide feedback and guidance on the framework for regulatory compliance of the CCTC platform and for the overall field of continuous bioprocessing.”
This project is set to last two years and ChromaTan expects to announce job openings in R&D management, process analytical technologies (PAT) and quality control, to be able to meet the proposed goals.