Outsourcing key to manufacture 'combo products'

Drug companies struggling to meet the unique testing guidelines, practices and regulations generated by the development and production of the new breed of "combo products" should rely on outsourcing, said Steven Richter, president of Microtest, a testing and contract manufacturing services provider. 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 combination, or combo, products is booming, said Richter. According to 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, according to recent research, an estimated 30 per cent of new products under development are combo products. However, for manufacturers, along with new market opportunities, the combination of drugs and devices also brings a host of challenges. "Most manufacturers' in-house labs are not yet ready in terms of the equipment, skills and experience needed to address the challenges of testing and validating combo products,"​ said Richter. "Many pharma labs don't have the expertise or facilities to address the processing of a physical product through their labs - let alone the skilled personnel knowledgeable in medical device testing and succeeding such a device through the FDA maze of regulatory issues,"​ he said. In addition, he stressed that medical device manufacturers generally lack the drug good manufacturing practice (GMP) systems to handle a combo product's pharmaceutical aspects. But that's not where the challenges end. According to Richter, the classification of the new combo products in terms of regulatory standards - whether it's a device, a drug or a biologic - are also posing problems. 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. "The solution, for many pharma and device manufacturers, is to outsource the testing and validation needs of combination products with an outside laboratory testing partner,"​ said Richter. Richter was speaking in advance of PharmaMedDevice 2007, the first conference and exhibition dedicated to advancing the combination products which will take place in New York City next month. "As we anticipate the issuance of new FDA guidelines specific to the research, development, production, and validation of combo products, the selection of an outsourcing laboratory testing partner is nothing less than a critical element for any manufacturer's successful development and production process of a new combo product,"​ Richter said.