The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/118943
Contract Sourcing Parenterals, Prefills, & Purity: Are Suppliers Up To The Challenge? S By Wayne Koberstein, executive editor omebody better be up to this challenge, or weÕre all in trouble. With more and more reliance on large-molecule drugs, the injectables market has soared just as shortages due to product contamination, recalls, and plant shutdowns have plagued companies and patients. The two crises are intimately related, and only an industrywide surge in investment for facility upgrades, mainly by suppliers, will address them both. From my earliest days in the pharmaceutical industry, production, storage, and distribution of parenterals have been the downfall of many companies. Typically, a Big Pharma will buy a smaller company with an injectables line. Boom Ñ within a year, the inspectors descend on the acquired facilities and lock them down. Headlines declare the companyÕs complacency toward product quality and patient safety. The company defends itself, shifting as much blame as possible to the company it acquired, as if it were just another innocent injured party in the unfortunate affair. Eventually large companies, presumably exhausted from repeating the experience with such acquisitions, began to rely increasingly on third-party suppliers. One effect was to spread drug production globally; many of the great pharma production centers in the United States and Europe have since closed in favor of outsourced manufacturers in India and other farflung facilities. CMOs took over some of the abandoned capacity in the West but followed the general trend toward worldwide production. One major result was that the sheer number of plants far outgrew regulatorsÕ 48 LifeScienceLeader.com ability to inspect and validate them. Lack of inspection is now a standard part of many suppliersÕ business models Ñ and if the pendulum were to swing toward greater enforcement as the FDA threatens, it would throw those companies into a financial sandtrap. The technologies that can ensure the purity of parenterals have existed for some time. Prefilled syringes or autoinjectors offer a general solution. One specific platform is aseptic blow-fill-seal (BFS), which I have described in the past. Avoiding microbial contamination on the shop floor by isolating the product from personnel and other sources and sealing it against exposure to further contaminants in distribution are the central challenges. But any new system that requires retrofitting or de novo construction will mean capital expenditures a given supplier may be unable to make. So the question of who is up to the challenge is more about economics and finances than technologies. REWARDS FOR HIGH QUALITY ARE LIKELY IN THE FUTURE Regulators may yet apply enough pressure to force widespread investment in the needed technologies. But even those who put their faith in market forces would accept the inevitability of a major shakeout among suppliers over this issue. Sooner or later, regulators and customers will find ways to punish the poor-quality producApril 2013 ers and lax distributors responsible for adulterated or counterfeited products, or related breakdowns in supply. There will be rewards as well for the suppliers who survive by maintaining or upgrading their production lines. One obvious reward would be entry into the burgeoning market for prefills. Prefilled injectors not only ensure sterility in manufacturing and distribution, but also cross-contamination between patients or providers at the point of care. Their ease of use, stability, and safety have created a growing demand and preference for them over traditional injectables. Other incidental benefits may also apply with prefills. One is materials saving due to reduction or elimination of overfilling Ñ one article I read claimed 20% more product yield because vials typically require the same percentage of overfill. Increased speed and flexibility of prefill production lines is another potential advantage. Prefill lines are also subject to greater automation, simplified cleaning, and less down time than traditional injectables. Still, I canÕt help but believe that the most compelling reason to adopt prefills is to upgrade the supply chain to a higher level of cleanliness. Yes, simple cleanliness should be the hallmark of any medical