Microtest Laboratories and Texcel Medical have teamed up to offer biopharma firms services to help them overcome the hurdles of developing "combination products" - a fast-growing market.
The two companies said they would combine their respective expertise to offer solutions they claim would help drug manufacturers with the design, prototyping, development, testing, approval, and manufacturing of combination or "combo 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 of Texcel. A combination product is comprised of two or more regulated components - a drug/biologic coupled with a device, or a drug and a biologic combined with a device - that are mixed and produced as a single entity. Such products are gaining in popularity as they are tipped to be safer and more efficient than standard drugs, have the potential to extend the lifecycle of existing drugs for manufacturers and, in some cases, can improve patient compliance. As a result market demand for combo products is booming, said Steven Richter, president of Microtest, a testing and contract manufacturing services provider. According to recent research from Navigant Consulting, the market for these products was worth $5.9bn (€4.4bn) in 2004 and analysts predict a 10 per cent annual growth rate will lift it to approximately $9.5bn in 2009. Richter added that an estimated 30 per cent of new products under development are combo products. The most recent combo product to be approved in the US by the Food and Drug Administration (FDA) is Neupro (rotigotine transdermal system), a skin patch manufactured by North Carolina-based Schwarz Bioscience to treat symptoms of early Parkinson's disease. "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," said Richter. Since 2002, the Office of Combination Products (OCP), which is part of the US Food and Drug Administration, is available for information and is there to ensure that pre-market reviews are conducted smoothly; however, actual reviews are done by the FDA and it can be tricky to determine the category in which of nine a combo product should fall. "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. Massachusetts-based Microtest brings both testing facilities and regulatory experience to the alliance, as well as comprehensive combination product solutions that include good laboratory practice (GLP) testing services, sterilisation validation, package testing, stability testing, biocompatibility testing, and clinical trial material application.
Meanwhile, Texcel also headquartered in Massachusetts, provides manufacturing infrastructure and engineering expertise for medical devices.