Cell Signaling Technology Expands Portfolio with GMP Capabilities

Cell Signaling Technology, Inc. (CST), a worldwide provider of high quality antibodies, announced today that their best-in-class recombinant rabbit monoclonal antibodies, developed with their proprietary XMT® and NG-XMTTM discovery technologies can now be manufactured according to GMP (Good Manufacturing Practices) requirements.

“As the fields of translational research and personalized medicine grow, our customers have increasing needs for antibody-based in vitro diagnostic (IVD) assays, which require exceptionally well-characterized, GMP-grade antibodies,” said Roberto Polakiewicz, Chief Scientific Officer at CST. “They can now use a single antibody clone with the specificity and sensitivity from a proven, trusted source from their research benches through to clinical applications, enabling continuity in their translational assay development efforts.”

CST’s broad portfolio of rabbit monoclonal antibodies includes pivotal translational targets, such as ALK, ROS1, and PD-L1. Today’s announcement follows a recent announcement from Ventana Medical Systems who received approval from the U.S. Food and Drug Administration (FDA) for an IHC companion diagnostic assay that utilizes the CST ALK antibody clone D5F3®.

The path to GMP capabilities at CST was paved by the addition of an 87,500 square foot manufacturing facility, which is ISO 9001:2008 certified and FDA compliant for GMP monoclonal antibody production.