Winston-Salem, NC – April 27, 2018 – Charter Medical Ltd., an innovative single-use medical device manufacturer, announced today that its Advect™ Fluid Transfer sets (formerly known as Cell Therapy Fluid Transfer Sets) are now FDA 510(k) cleared and CE Marked. They are available in the U.S. and EU and are intended for sterile transfer of bone marrow mononuclear cells from one container to another. These fluid transfer sets are the first to be developed and offered with an intended use to support cell therapy manufacturers.
As the cell therapy industry continues to grow at an exponential rate, there is an increased need for products that can support the clinical and commercial therapeutic pipeline. For cell therapy manufacturers, a controlled, robust, and reproducible manufacturing platform is essential to their success.
The Advect™ Fluid Transfer sets’ device components, testing and final product packaging are compatible with cleanroom manufacturing requirements, while the intended use and regulatory approval help facilitate global technology transfer for clinical and commercial production of cell therapies and personalized medicines.
“We are committed to providing products and solutions the cell therapy industry requires,” said Gael Peron, President, Charter Medical. “Our Advect™ Fluid Transfer Sets are designed specifically to support cell therapy manufacturers, giving them confidence to successfully sterile transfer material at every step. With our regulated products, customers can bring their products to patients, faster.”
About Charter Medical Ltd.
Charter Medical helps produce safe and effective medicines by designing and manufacturing single-use solutions for cell therapy, bioprocessing, blood transfusion and blood filtration markets. Charter Medical is a wholly owned subsidiary of Fenner PLC (LSE:FENR) and operates out of an ISO 13485 certified and FDA registered manufacturing facility in Winston-Salem, NC. To learn more, visit http://www.chartermedical.com.