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Microtest Labs, Texcel Medical Join Forces for Combo Product Testing

PharmaManufacturing.com
06/19/2007

Microtest Laboratories and Texcel Medical on Jun 19 announced a strategic alliance to provide pharmaceutical manufacturers and biotechnology companies with a competitive advantage when developing the latest breed of “combination products.”

An estimated 30 percent of new products under development this year are combo products -- consisting of medical devices embedded with pharmaceutical or biologics components.  Growing at a 10 percent compound annual growth rate, the market is expected to reach approximately $9.5 billion in 2009.

“The combination products market is booming. Yet, many pharmaceutical companies are struggling to manage the convergence of devices and drugs or biologics and the host of unique FDA testing guidelines, practices and regulations that such products require,” according to Steven Richter, Ph.D., president, Microtest.

“For such firms, outsourcing is the solution – provided that the arrangement is struck with the right partner.  This is the strategy behind the Microtest/Texcel alliance,” Richter said.

Microtest, based in Agawam, Mass. is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.  The company brings both world-class testing facilities and deep regulatory experience to the alliance, as well as comprehensive combination product solutions that include GLP testing services, sterilization validation, package testing, stability testing, biocompatibility testing, and clinical trial material application.

Texcel, of East Longmeadow, Mass. provides manufacturing infrastructure and engineering expertise for surgical, interventional, and implantable medical devices.  The firm completes the alliance’s offering for pharma manufacturers with a host of solutions for active implantable devices – and an ISO 13485:2003, ISO 9001:2000 and FDR registered facility. 

“Together, we offer a unique, seamless synergy of expertise in the design, prototyping, development, testing, approval, and manufacturing of combination products.  For pharma companies, the result is an instant competitive advantage and acceleration in time-to-market in an increasingly fast-moving, competitive, and global economic market,” said Larry Derose, president, Texcel.

For more information on Microtest, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.  For more information on Texcel, visit www.texcelaser.com or call 1-413-525-5700 or toll-free 1-800-754-1800.