CaridianBCT and Terumo Transfusion unveiled plans to join the two companies into Terumo BCT at this year’s American Assn. of Blood Banks meeting.
The two companies will operate independently until spring 2012 when they will combine to form blood component technology company Terumo BCT.
"When our integration is complete, Terumo BCT will focus its long-term vision on increasing the value of every donation, expanding the number of treatment options for patients and enabling scalable production of cell therapies," said David Perez, Terumo BCT president & CEO, in prepared remarks. "Our goal is to continue creating value through innovation and integration, together with our customers."
The new organization will provide a wider range of manual and automated whole blood processing and pathogen reduction solutions with cell processing technologies and therapeutic apheresis, according to the company.
"Drawing from both companies, we will bring together the industry’s best people, products and processes to deliver on this commitment, as well as to unlock the potential of our customers’ business and the treatment options that target improved customer efficiencies and patient outcomes," added Perez.
Terumo Cardiovascular Systems was required to pay the FDA $35 million and had a stop put on some product sales until it completes an FDA-approved plan to fix manufacturing problems at a plant in Ann Arbor, Mich.
The Terumo Corp. subsidiary agreed on the terms of a consent decree with the federal watchdog agency, including a $35 million fine payable to the FDA. The company must also correct deficiencies in the plant’s quality system; until then, the manufacture of numerous Terumo Cardiovascular products are prohibited or restricted.
The FDA issued two warning letters to Terumo CVS about current Good Manufacturing Practice problems, once in 2004 and once in 2006, according to the agency.