The $2.5m (€2.1m) grant from the US Food and Drug Administration (FDA) will be used to develop the Continuous Countercurrent Tangential Chromatography (CCTC) platform at ChromaTan’s laboratory located in West Philadelphia
Oleg Shinkazh, ChromaTan’s founder and CEO, told Biopharma-Reporter the two-year project was part of the 21st Century Cures Act – signed into law in December 2016 – which has dedicated funding to support advanced manufacturing initiatives and continuous bioprocessing.
According to Section 3016 of the Act, the US Health and Human Services department (under which the FDA falls) may award grants “for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.”
Shinkazh could not make any statements related to the FDA and its motivations. “That's explicit in the contract.”
Continuous chromatography is an area which has been cited as “the next logical step” in bioprocessing, and Shinkazh spoke to us in June about the need to develop such processes to reduce the costs of making biological products, on the back of his firm’s deal with Wales, UK-based bioprocessing resin maker Purolite for the supply of Protein A resin in the CCTC system.
The project aims to develop a platform that can continuously purify a monoclonal antibody (mAb) harvested from a CHO cell-based bioreactor system through multiple purification modalities, and will include process development, design, and testing of a multi-unit operation process train.
It will also create three jobs this to be filled this year, and potentially a further three to be filled in 2018, Shinkazh said.