J. CALNAN & ASSOCIATES CELEBRATES GRAND OPENING OF ACCELERON PHARMA’s cGMP MANUFACTURING FACILITY

J. CALNAN & ASSOCIATES CELEBRATES GRAND OPENING OF ACCELERON PHARMA’s cGMP MANUFACTURING FACILITY

5/8/2009, Quincy, MA — J. Calnan & Associates, one of New England’s leading construction management firms specializing in pre-construction services and challenging construction projects, recently joined Timothy Murray, Massachusetts Lt. Governor; Gregory Bialecki, Massachusetts Secretary of Housing and Economic Development; Robert Coughlin, President and CEO of the Mass Biotechnology Council; Richard Pops, Chairman of Alkermes, Inc.; Susan Windham-Bannister, President & CEO of Massachusetts Life Sciences Center; John Knopf, CEO of Acceleron Pharma and many other distinguished guests to celebrate the grand opening of Acceleron Pharma’s new cGMP clinical manufacturing facility.

 

Acceleron is a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including bone, muscle, red blood cells, and vasculature. Acceleron’s lead program, ACE-011 is currently in phase 2 studies in multiple myeloma patients with osteolytic bone disease and is being jointly developed by Acceleron and Celgene Corporation. Acceleron’s second program, ACE-031, which is currently in a phase 1 study, is designed to increase skeletal muscle mass and strength, and also decreases fat mass. ACE-031 has shown encouraging preclinical results in animal models of age-related muscle loss, neuromuscular disease, cancer treatment-related muscle loss and metabolic diseases. The company plans to bring its third program, ACE-041, a novel, non-VEGF-based angiogenesis inhibitor that blocks the development of vasculature in tumors, into the clinic by the end of 2009.

 

The project team of J. Calnan & Associates, Industrial Facilities Design Inc., 20/20 Engineering and Niall Johnson Consulting worked seamlessly to deliver Acceleron’s new state-of-the-art facility on time, within budget and according to cGMP standards. The project included the total renovation of all 38,000 square feet of the existing facility to help Acceleron expand its research and testing. In conjunction with the renovation, JCA completed the new construction of a 13,000 square foot cutting-edge cGMP Clinical Manufacturing Facility, multiple support labs and 12,000 SF of office space. In order to keep Acceleron fully operational, the JCA team worked hand-in-hand with the Cambridge regulatory agencies and the Acceleron team to appropriately phase in Acceleron’s occupancy. In addition, the construction team developed a commissioning plan in the early stages of the project that was implemented throughout the entire process. This plan ultimately assisted in verifying that all of the building systems were properly installed, functioned correctly, and produced the expected results upon turnover to the client for continuous use. This upfront planning and documentation was instrumental in ensuring that the validation process went as planned, avoiding any potential delays that could have jeopardized the opening date of the facility.

 

“J. Calnan and Associates is an extremely knowledgeable and service-oriented company that understands our needs,” said Nancy Sullivan, Director of Operations at Acceleron Pharma. “Through their up-front planning, hard work and commitment to our team, we were able to continue our mission of bringing life-changing therapies to patients, without being disrupted by construction issues.”

 

“We’re thrilled with the relationship we’ve formed with Acceleron Pharma over the last 2 1/2 years,” said Jim Cahill, Vice President for J. Calnan & Associates. “The research and testing that companies like Acceleron Pharma are doing continues to give hope to millions of patients who are in need of these critical breakthrough therapies. We are extremely proud of our involvement with Acceleron and look forward to continuing to provide our world-class services to the life sciences community.”

 

 

The Acceleron Team (from left to right): Brian Mikolaycik, Project Manager, JC&A; Jim Cahill, Vice President, JC&A; Jim Gunning, Superintendent, JC&A; John Knopf, CEO, Acceleron Pharma; Bob Coughlin, President, Massachusetts Biotechnology Council; Jay Calnan, President, JC&A; Steve Robak, Project Executive, JC&A.

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