How Important Is The Single-Use Supplier Relationship?
By Trisha Gladd, Editor, Life Science Connect
In recent conversations with industry experts about the trends they expect to impact the biopharmaceutical industry in 2016, many noted the continued development of flexible manufacturing solutions as one to watch. This, of course, includes single-use technology (SUT), which is expected to grow to a value of nearly $3 billion by 2019.
In a survey conducted by Pharma IQ for 2015, which captured the industry’s view on SUT and what challenges it faces, over 100 users were asked about their relationship with their SUT supplier. While many voiced satisfaction with their suppliers (89 percent stating they used more than one), 27 percent said they were not happy (specifics were not provided). Of the most important factors identified when choosing a single-use supplier, 64 percent of respondents indicated that the relationship with the supplier ranks as the most important.
No More One And Done
As Kimball Hall pointed out in her BioProcess International 2015 keynote presentation, the implementation of single-use technology requires a stronger relationship with a company’s supplier than when a company is implementing stainless steel because it continues beyond a one-time exchange. “Our relationship with our vendors is no longer transactional,” she explains. “They are deeply embedded in our lives. It used to be you go to a stainless steel bioreactor and it’s yours. You can pressure test them; you can fix leaks, if you have them. That is your piece of equipment. Going into single use equipment, your vendor’s supply chain is now an extension of your own, and you have less control over it. You have to think differently about its robustness as well as have a deeper knowledge about where you might have problems.”
At Amgen’s “next gen” facility in Singapore, Dr. Hall says a very strong relationship with vendors was forged early on, and the benefits have gone a long way. “We have spent an exorbitant amount of time over the last four years working very heavily with our vendors and have worked with them in finding solutions in different ways,” she says. “They have been with us along the way, and since we started our PPQ [Process Performance Qualification] runs in August, our vendors have been sitting in our cafeteria waiting to help us load the bags and waiting to troubleshoot issues if we come into problems. We know how important they are to us, and they recognize that relationship too.”
Stronger Standardization Efforts Could Provide Much-Needed Boost
In an article written by Eric Langer, president and managing partner of BioPlan Associates, data from the company’s 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production shows that increased efforts toward standardization by SUT suppliers could lead to higher satisfaction with industry vendors. The last year has seen some momentum toward standardization—such as BPOG’s extractables testing protocol released a year ago as well as PM Group’s online equipment standardization project launched last month—however, there seems to have been little push from vendors outside of these efforts to progress the movement forward.
In Langer’s report, he states, “When we asked the more than 200 qualified biopharmaceutical manufacturers we surveyed this year to cite the single most important biomanufacturing trend on which the industry must focus its efforts this year, respondents were far more likely to point to single-use implementation and integration (9 percent of respondents) than they were to better single-use devices (4 percent).” He continues, “In other words, as disposable devices reach mainstream adoption, the focus becomes an issue of implementation as opposed to innovation.” Therefore, if the industry could reach a level of standardization within SUT (such as with equipment or extractables and leachables testing), concerns about implementation could be alleviated, potentially leading to increased adoption.
So while the continued development of flexible manufacturing solutions is certainly something to keep our eye on, the success of those solutions will likely depend on what kind of relationship exists between users and suppliers. Stainless steel has created a culture where those worlds did not have to be intertwined. SUT challenges that tradition and forces stronger partnerships. Do you think pharma is ready to bridge that gap?