- Kindeva has installed a second Optima 10-head prefilled syringe (PFS) filler line at its 155,000-square-foot fill-finish facility in Bridgeton, Missouri, with initial qualification activities completed.
- The additional line supports Kindeva’s aseptic manufacturing capabilities, with the facility designed to produce more than 150 million units annually and expand beyond 200 million units in the future.
Kindeva, a global drug delivery contract development and manufacturing organization (CDMO), has installed a second Optima 10-head prefilled syringe (PFS) filler line at its fill-finish facility in Bridgeton, Missouri. Initial qualification activities for the new line have been completed, adding capacity for biologics and other complex drug products.
The 155,000-square-foot facility provides aseptic fill-finish, clinical supply and commercial manufacturing services. It supports manufacturing in vials, prefilled syringes and cartridges through high-speed isolator filling lines. The two Optima PFS lines can fill 0.5 mL to 50 mL syringes at speeds of up to 300 units per minute, with automated in-process controls for weighing and stopper height. Together, the lines can fill 60 million to 100 million units annually.
The Bridgeton facility also includes a Groninger eight-head vial filler and a Syntegon 18-head cartridge filler. The vial line can produce 30 million to 50 million units annually, while the cartridge line can fill 20 million to 50 million units annually. The facility has been designed in line with Annex 1 principles, with capabilities intended to enhance product quality and minimize operator intervention.
Kindeva said the facility is designed to produce more than 150 million units annually, with future capacity planned to exceed 200 million units. The company said the site supports projects across key development and manufacturing milestones, including technical and regulatory requirements. The facility is supported by teams across sterile manufacturing, formulation, analytical, regulatory and quality functions.
“The future of injectable medicine is increasingly patient-centric, with more treatments moving beyond the hospital and into the home. Prefilled syringes and cartridges play a critical role in this transformation, enabling safer, more convenient administration while serving as the foundation for many advanced drug-device combination products.”
David Stevens, CEO of Kindeva
