NeoStem, Inc., a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced today that PCT has expanded both its Allendale, NJ and Mountain View, CA current Good Manufacturing Practice ("cGMP") facilities to significantly increase its engineering and process development laboratories, and controlled environment ("clean room") space available for client needs. Furthermore, the expansion in the Allendale, NJ facility features an ISO Class 6/1,000 clean room, enabling PCT to manufacture products intended for European distribution.
"The expansion of our facilities is well in line with the growing demand for PCT's contract development and manufacturing services," said Dr. Robert A. Preti, Chief Scientific Officer of NeoStem and President of PCT. "PCT has always prided itself on delivering excellent customer service and now we can offer our clients more capacity and options for solutions at our facilities to expedite the development and manufacture of their cell therapy products. The non-clean room expansion activities will both improve our capability to provide product development support, and importantly provide room for PCT's Engineering and Innovation Center to grow."
PCT's Allendale facility added two clean rooms for a total of five, an increase of 67%. One of these new clean rooms is ISO Class 7/10,000 and the other is ISO Class 6/1,000, meeting certain compliance requirements for product distribution into the European Union. Additionally, the facility expansion added a process development laboratory and effectively doubled available office space. At this point, approximately 22,000 of the Allendale facility's approximate 30,000 sq.ft. of space has been developed, allowing for the possibility of additional future expansion.
The Allendale facility expansion was designed by Poskanzer Skott Architects of Ridgewood, NJ, an award-winning design and planning firm recognized for its innovative and workable design solutions. "Our work for PCT has taken our firm's involvement in the high-tech/sciences sector to a new level," said the firm's co-founder, Barry Poskanzer, AIA. "We take great pride in the quality and longevity of our relationship with PCT, an exciting company doing cutting-edge work in support of medical advancements."
PCT's Mountain View facility expansion added a clean room for a total of six, an increase of 20%. The new room is a 250 sq. ft. ISO Class 7/10,000 clean room. This expansion brings the production area of the facility to approximately 17,000 sq. ft., reserving approximately 8,000 sq. ft. for future development.
"This investment into PCT's manufacturing facilities and the expansion of its capabilities demonstrates our commitment to support the significant growth and advancement of the regenerative medicine industry, both in the U.S. and in Europe," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.