New Vetter clinical syringe packages – Potential to reduce time to market
Press Release | Vetter Pharma International GmbH
APRIL 22, 2014
Ravensburg, Germany: – A leading contract development and manufacturing organization (CDMO) Vetter, introduced two new clinical packages that facilitate starting syringe development earlier in the drug development process.
Traditionally, companies begin syringe development only after vials near completion of Phase III trials, typically taking up to two years to complete the transition to syringes, including packaging selection through validation/registration runs.
Now Vetter’s self-contained, modular syringe packages provide clear road-maps through the development process, making it easier to develop the syringe fully or partially in parallel with the vial. This offering can reduce transition time by as much as 18 months, depending upon when syringe work begins and the complexity of the compound.
Two level approach
Vetter has developed two new packages.
The Clinical Syringe Standard Package includes all development activities through to launch. This all-inclusive service starts with materials selection; the best combination of syringe, needle and stopper to meet a compound’s requirements; and continues through to FDA Good Manufacturing Practice-compliant (cGMP) clinical syringe filling.
The Clinical Syringe Starter Package offers a range of feasibility tests that can be run independently of financial commitment to a clinical fill. This package also starts with materials selection, proceeds through feasibility testing and regulatory consultation, concluding with a non-cGMP stability run.
Even if not planning an immediate launch in syringe, predetermining syringe feasibility enables more nimble responses to changes in market or business priorities. It may also enhance product attractiveness when out-licensing. Both packages can be customized to the compound and to the business goals of the developer.
Launching directly in a prefilled syringe, rather than vial-only can differentiate products in a marketplace eager for patient-friendly systems. Moreover, it may be easier to recruit medical clinics for trials that use prefilled syringes, since they require less handling and preparation than vials, with reduced risk of needle-sticks.
Moving with the market
Vetter managing director Peter Soelkner commented: “As the market moves toward prefilled syringes, we wanted to enable our customers to make an earlier start on syringe development, where this suits their compound and their business goals.”
“Our new clinical syringe packages, coupled with the development expertise of our scientists and the advanced technology of our facilities, give our customers an easier way to pursue syringe work earlier,” said Mr. Soelkner.
Vetter scientists and engineers have extensive experience developing manufacturing processes for complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Vetter’s Chicago facility is entirely dedicated to clinical manufacturing, including a disposable platform and short tubing lengths to minimize active pharmaceutical ingredient (API) loss. Currently offering semi-automatic clinical syringe filling, Vetter Chicago will launch a fully automatic clinical syringe line later this year. The company’s German facilities also offer clinical syringe filling. At Phase III, products are transferred to Vetter’s commercial manufacturing operations for large-scale production and global supply.
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s ten top pharma/biotech firms.
A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. Vetter employs approximately 3,300 staff across Europe and the United States.
Oskar Gold, Vetter Pharma International GmbH
Tel: +49 (0)751 3700 3729