Founded in 2002, Cellex Incorporated is a biotechnology company that develops technologies, instruments and assays for testing of human diseases and conditions, particularly at point-of-care (POC) settings.
Cellex was founded in the state of Maryland. Cellex moved its main operation to the Research Triangle Park (RTP), North Carolina, USA, where its main R&D staff is located. In addition to the R&D laboratories, Cellex also has a manufacturing facility at RTP, which is used to develop manufacturing capabilities. Cellex maintains a GMP manufacturing site in Suzhou, China, which is ISO 13485 certified and in compliance with U.S. FDAs QSR (Quality System Regulation).
Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have ample experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD.
Our R&D facility is fully-equipped with modern laboratory spaces. The general laboratory space is divided into dedicated spaces for work in molecular biology, immunology and immunochemistry, microbiology, cell culture, and manufacturing process development. It also has a separate microbiology laboratory designed for work requiring BSL-2 containment conditions.
Our manufacturing facility is ISO 13485 certified. The facility is fully equipped to perform the conjugation of purified antigens or monoclonal antibodies to a marker. Our capabilities include production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation.