The focus on customer service and a supplier’s ability to provide good product life-cycle management, followed closely behind process integrity (both at 50%) as key criteria when evaluating suppliers. For many companies, operational excellence is predicated on equipment and process reliability, critical attributes of compliant high-quality drug manufacture that the industry is increasingly reliant on its strategic equipment suppliers to provide.
Pharma manufacturers are turning to technology and systems suppliers for technological expertise that once was held internally. This capability was once institutionalized and nurtured, a product of vertical-integration-based business models and large-capacity processing lines that required an amazing amount of proprietary engineering to manage correctly. That’s changed, and the expertise is now housed in the supplier sector.
Single-use technology, innovated by some of the industry’s most prominent suppliers, is increasingly being integrated into processing operations, both upstream and downstream. An example of this is the agreement between PnuVax Inc., a vaccine processor, and GE Healthcare. Under this partnership arrangement, PnuVax Inc. has the liberty to assume the intellectual property (IP) generated from GE Healthcare’s non-activated yellow fever vaccine, as well as the biomanufacturing platform for the vaccine, GE Healthcare’s FlexFactory™. Both companies are working together to streamline manufacturing, as part of this symbiotic partnership.1
Collaboration, often leading to strategic partnerships with suppliers, has become an industry standard practice. This is especially clear in the realm of biologics, for which manufacturing is often based on proprietary process developed in conjunction with the molecule. Reflecting the drive to compete in the biologics sector, purchasing biopharmaceutical equipment is top-of-mind for 81%. Those thinking about purchasing equipment are interested in both upstream and downstream biopharmaceutical processing components and systems. A solid third expressed interest in technologies critical to upstream processing, including incubators, cell culture biological shakers and tank equipment (37%, 32% and 30%, respectively). Although specifying and purchasing upstream technology is a significant priority, downstream bioprocessing equipment is becoming an intensive area of focus as well, because so much can be gained if downstream processes are optimized. A majority of those who work in operations leadership in the biopharma sector are currently interested in obtaining purification equipment, filtration equipment (50% each) and, to a slightly lesser degree, disposable equipment, separation equipment and chromatography equipment (39%, 38% and 36%, respectively).
Downstream processing requires a strictly regulated aseptic environment, followed by a broad range of finishing and packaging routines that involve highly automated, integrated drug-product handling systems. Purchasing interest is high for both primary packaging systems, including aseptic filling and sealing/capping equipment and blow-fill-seal systems for sterile, parenteral drugs (41% and 34%, respectively). New drug delivery methods, including transdermal patches, inhalers and injection devices, are also working their way into drug owner or developer packaging and delivery strategies; 32% are interested in installing product assembly lines for inhalers and patches. Similarly, there’s mounting evidence that the role of secondary packaging is gaining new relevance in promoting safer, more effective drug-based therapies to fight the scourge of substandard, dangerous counterfeit drugs. On the purchasing priority list for many are serialization equipment (34%) and tamper-evident solutions (33%).
RJ has over 30 years’ business experience, including 21 years of event and media experience and 17 years in leadership positions. RJ progressed from Sales Manager to VP/General Manager on Interphex, the leading event in North America for Development & Manufacturing. RJ has also been an active participant in ISPE and PDA. RJ was one of the original team members and architects for ISPE’S Facility of the Year, a former member of the ISPE Supplier Advisory Council and currently serves as a trustee for the Health Sciences