Under the new deal the non-glass device – a 1mL long insert needle and syringe produced in conjunction with Japanese manufacturers Daikyo Seiko – will be filled at Vetter’s aseptic facility in Germany.
In a joint statement, the companies said the deal was in response to issues with current pre-filled syringes on the market as well as the on-going stress on cGMPs (current good manufacturing practices) and pharmaceutical practices.
The prefillable syringe system includes a piston and nozzle cap with Daikyo Flurotec barrier film on the drug contact surfaces, providing a barrier between organic and inorganic extractables.
The device also and eradicates the need to apply silicone oil for lubrication – a leading cause of protein aggregation and immunogenicity risk – as with many syringes currently on the market.
Mike Schäfers, VP of marketing Europe at West, told Outsourcing-Pharma: "By choosing the Daikyo Crystal Zenith syringe system, pharmaceutical and biopharmaceutical companies can package and deliver their drug products in a system that is highly break resistant and is free of silicone oil and tungsten.
"As a result, they can solve issues related to breakage and reduce the potential interaction between the drug and the containment system."
Coming to America
Media fills and equipment validation are now underway for the 1mL long insert needle syringe system at Vetter’s plant in Germany.
However the company have also invested in filling capabilities for the product at their new facility in Chicago.
“Our filling capabilities for the new syringe will be based in Germany at first, but we will also work in Chicago at a later date. The investment is already in Chicago,” Oskar Gold, VP and president of international business development and corporate marketing at Vetter told Outsourcing-Pharma.
When asked if Vetter’s Chicago facility, opened last month, was due in part to the West deal in the pipeline, Gold would added: “The general target of Chicago was to get closer to our customers in the US, and to be able to offer them more support in early development.
“Most of our clients are US based, so this made sense.”
The news comes just after West issued its Q3 results, in which it stated an unexpected growth in its pharmaceutical drug delivery sector.
The firm also said it expects growth in the pre-filled pharmaceutical packaging sector, driven by “high-value packaging and prefilled syringe components”.
Now, thanks to the development potential in delivery systems and packaging, West has updated its long-term strategic plans.
In the results, released on November 1st, West stated: "We have updated our long-term strategic planning goals as part of our annual five-year planning process.
“We expect modest growth from proprietary devices next year, as development work for the SmartDose electronic patch injector continues, and our customers execute their pre-marketing and manufacturing trials for Daikyo Crystal Zenith products.
“The significant growth opportunities for those products still lie beyond 2012.
“Based on the persistent strength of our Pharmaceutical Packaging Systems business and the visible growth potential within the Pharmaceutical Delivery Systems segment, we currently estimate that the growth potential of these combined businesses will generate revenues between $1.7 billion and $1.9 billion in 2016, with operating margins in the high teens.”