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news.Life Technologies Corporation's OpTmizer CTS T-Cell Expansion Tissue Culture Medium has received FDA 510(k) clearance as a Class II medical device to transit studies from the research bench to clinical trials.
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The OpTmizer CTS, as a human ex vivo (outside the body) tissue and cell culture processing application develops therapeutic T-cells to treat diseases including cancer, infectious diseases such as AIDS and autoimmune disorders.
Opexa Therapeutics president and CEO Neil K. Warma said, "We are very pleased to learn of Life Technologies’ successful outcome in achieving its FDA 510(k) regulatory clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium, and we value the close working relationship we have established with Life Tech."
OpTmizer CT provides a xenofree formulation that reduces variability during the development of T-cell therapies.
The medium’s effectiveness in rapid T-cell expansion at high cell density reduces media usage resulting in cost savings for end-users.
It is currently being used in multiple clinical trials in the US and complements other Life Technologies Cell Therapy Systems (CTS) products that have previously received 510(k) clearance by the FDA.
Life Technologies primary and stem cell systems general manager and vice president Chris Armstrong said, "The FDA’s clearance of our product for culturing T-cells is an important step in that direction and supports our commitment to offering our customers leading products that drive their translational research."