Life Technologies Corporation has announced that it has received FDA 510(k) clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium - a reagent that is now cleared as a Class II medical device and offers cost- and time-saving advantages for transitioning studies from the research bench to clinical trials.
The OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium is intended for human ex vivo (outside the body) tissue and cell culture processing application.
This means it is designed to efficiently grow large numbers of potentially therapeutic T-cells, which have demonstrated promise in clinical studies as an effective treatment for diseases including cancer, infectious diseases such as AIDS, and autoimmune disorders.
"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," said Neil K. Warma, President & CEO of Opexa Therapeutics, Inc.
Warma continued, "The receipt of 510(k) status for OpTmizer CTS T-cell expansion media simplifies the regulatory path for Opexa as we continue the development of Tcelna™, a T-cell immunotherapy for the treatment of patients with multiple sclerosis."
As a product that is manufactured following GMP requirements in an ISO 9001/13485 certified facility, OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium provides a xenofree formulation, containing defined components that can help reduce variability during the development of T-cell therapies.
The ability to document manufacturing process details, quality control testing and component traceability streamlines the review process when submitting Investigational New Drug (IND) applications to the FDA as required for clinical trial initiation.
Its effectiveness in rapid T-cell expansion at high cell density can reduce media usage, which results in end-user cost savings.
OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium is currently being used in multiple clinical trials in the United States. It complements other Life Technologies Cell Therapy Systems (CTS™) branded products that have previously received 510(k) clearance by the FDA.
They include: AIM V® Medium, DMEM, KnockOut™ SR Medium, KnockOut™ SR XenoFree Medium and StemPro MSC SFM CTS.
The company's portfolio of solutions addresses a wide range of cell types and procedures including the isolation, expansion, differentiation and characterization of cells.
"The availability of validated tools for use in clinical trials is one of the key steps to realizing the potential for stem cell therapy," said Chris Armstrong, Ph.D, General Manager and Vice President of Primary and Stem Cell Systems at Life Technologies.
Armstrong continued, "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."