Drug-delivery systems that ease patient administration are in demand. “There’s a big trend toward self-administration,” reports Mike Schaefers, vice president, global product management and marketing operations for West Pharmaceutical Services Inc. He points to interest in “pen injectors, for insulin as well as biologics as one important option."
Many of today’s new biologic drugs, however, won’t see the blockbuster demand that traditional pharma drugs saw years ago, so packaging and processing costs for short runs can be a concern. “There will be fewer blockbuster drugs in terms of units,” says Schaefers. For instance, “a lot of biologics in cartridges are only 1 to 5 million units per year, versus the large-scale manufacturing that pharma companies are used to.”
Manufacturers are therefore looking for economically feasible options for filling smaller quantities. A new partnership between West and Ompi offers a potential solution for streamlining cartridge filling while achieving the high levels of quality expected.
Mike Schaefers, vice president, global product management and marketing operations for West Pharmaceutical Services Inc.
West and Ompi’s solution is based on ready-to-use cartridges and components. The two companies presented a poster on the system at the European PDA in late 2015, and they will be on hand to discuss the technology at the upcoming Pharmapack Europe February 10-11 in Paris, with West in Booth #538 and Ompi in Booth #906. The ready-to-use system accommodates what Schaefers describes as “adaptive” or “flexible” filling. (Schaefers also hosted a workshop on flexible, adaptive filling at the European PDA.)
Flexible filling employs just one machine that can handle cartridges, syringes, or vials packed in Nest & Tub (N&T). Such technology can provide the needed economies of scale for smaller quantities in terms of units, Schaefers explains.
Nested cartridges for such tray-based filling systems have been a trend for about 4 to 5 years. Now West and Ompi are partnering to provide the next evolution with high-quality, ready-to-use nested cartridges and components for tray filling. The two companies “identified the need for high-end, ready-to-use cartridges with high-quality components,” he says, to meet the needs of “very sensitive biologics” that are also “more costly."
Ready-to-use components eliminate the need for and cost of in-house processing and sterilization prior to filling, streamlining production. Validated products to reduce particle levels can be offered in specific sizes, West and Ompi report.
Partnering to provide ready-to-use cartridges in N&T and elastomeric components was the logical next step for Ompi and West. Ompi, which manufactures a range of pharma containers from glass tubing, launched its sterile, ready-to-fill EZ-fill syringes in 2007, which later led to EZ-fill vials and cartridges. And West has long offered Westar stoppers, plungers, and seals that can be supplied either ready to sterilize or ready to use.
"Combined, we provide great experience in glass and rubber,” says Schaefers of the partnership. “We needed to get together to provide more data on a [ready-to-use] system, chemically and functionally. Companies want more science, more know-how. And now West and Ompi can collectively take a systems approach, joining forces to benefit the industry.”
For instance, West and Ompi are working together to build technical data on glide force and break loose, which is the initial force needed to get the plunger moving, he explains.
Schaefers believes that industry will appreciate such data because it is seeking a better understanding of how “containers and components influence the functionality of a device.”
And such information may have wider implications for patient outcomes. “Easy-to-use delivery systems can be key enablers of patient compliance,” Schaefers says, adding that "this is critical in a pay-for-performance market climate in which payers have to show the benefit of therapies.”
And be sure to visit West in Booth #538 and Ompi in Booth #906 at Pharmapack Europe February 10-11.