Vetter, a contract development and manufacturing organization (CDMO), has introduced two clinical syringe packages that make it easier to start syringe development earlier in the drug development process. Starting syringe work earlier, in full or partial parallel with vial development, can cut up to 18 months off time-to-market. Vetter’s self-contained, modular packages are designed to provide a clear roadmap through the syringe development process, making it easier to jumpstart syringe work. Vetter’s Clinical Syringe Standard Package includes all development activities through launch; the Clinical Syringe Starter Package offers a range of feasibility testing without the financial commitment to a clinical fill.
Vetter’s Clinical Syringe Standard Package provides all-inclusive service, starting with materials selection – the best combination of syringe, needle and stopper to meet a compound’s requirements – and continuing through cGMP clinical syringe filling. The Clinical Syringe Starter Package starts with the same materials selection, proceeds through feasibility testing and regulatory consultation, and ends with a non-cGMP stability run. Even if not planning an immediate launch in a syringe, predetermining syringe feasibility enables a nimble response to a change in market or business priorities; it may also enhance product attractiveness if seeking to out-license. Both packages are customizable to the needs of the compound and to the business goals of the innovator.
Potential to cut up to 18 months off launch timeline
Traditionally, companies begin syringe development only after vials near completion of Phase III. It typically takes up to two years to complete the transition to syringes, from packaging selection through validation/registration runs. Starting syringe development earlier can cut transition time by as much as 18 months, depending upon when syringe work begins and the complexity of the compound.
Launching directly in a prefilled syringe, when appropriate, rather than vial-only first, can differentiate products in a marketplace hungry 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 and have reduced risk of needle-sticks.
Development experience and infrastructure
“As the market moves toward prefilled syringes,” said Vetter managing director Peter Soelkner, “we wanted to enable our customers to get an earlier start on syringe development, when it 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.”
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 API loss. Currently offering semi-automatic clinical syringe filling, the Chicago site 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.