Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider with a select therapeutic development pipeline, announced a new five-year strategic manufacturing services agreement under which PCT will produce SPEAR T-cell therapies for Adaptimmune Therapeutics plc. PCT, through dedicated, specialized staff and facilities, will produce the SPEAR T-cell products at its Allendale, New Jersey facility in a manner compliant with both US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations.
PCT’s relationship with Adaptimmune is intended to provide Adaptimmune with operational flexibility for the manufacture of its SPEAR T-cell products from development through clinical manufacturing and, ultimately, subject to marketing authorizations, into commercialization.
“PCT is an elite contract manufacturing organization in the field of patient-specific cell therapies, and we are very pleased to strengthen and develop our existing relationship,” said Dr. Gwendolyn Binder-Scholl, Adaptimmune’s chief technology officer. “We have worked with PCT over the past three years and their commitment to high quality manufacturing, allied to timely delivery, makes them an ideal manufacturing partner for Adaptimmune. This arrangement will complement well our new manufacturing plant currently under construction in Philadelphia.”
“We are delighted to expand our relationship with Adaptimmune. This extension is a perfect example of our ability to service our clients’ needs from earlier-phase clinical trials through development toward commercialization,” said Robert A. Preti, PhD, president of PCT and senior vice president, manufacturing and technical operations of Caladrius Biosciences. “We appreciate Adaptimmune’s continued confidence in PCT’s ability to support their groundbreaking technologies in the US and Europe.”