Fresenius Kabi invests in Pre-Filled Syringe Capacities for US and EU supply

As a safe, effective and convenient way to administer injectable medications, pre-filled syringes (PFS) have become the injection system of choice for a growing number of drugs. PFS allow healthcare professionals to easily handle syringes, reduce waste and save time by providing a ready-to-use container, while also allowing them to precisely dose and minimize overfill.

Fresenius Kabi has implemented pre-filled syringe technologies at its manufacturing sites in Graz, Austria and Wilson, USA. Both sites have long experience with this drug delivery system and offer our customers contract manufacturing services and seamless support throughout the entire life cycle of their syringe products. We accompany our partners from the early stages of development right through to the commercial manufacturing and offer pre-filled syringes from 0.5 mL – 50 mL format for high-volume low-complexity products to high-complexity products with customized adaptations to the process.

Recent investments in Graz, Austria and Wilson, North Carolina

Following the company’s philosophy of caring for life, Fresenius Kabi now invests further in its Graz facilities in Austria. The investment project of more than € 60 million is a clear commitment of the company to the region and scheduled for completion in 2023. It will expand the manufacturing and packaging capacities of its two locations in the Austrian city of Graz. Specializing in complex products and processes, Fresenius Kabi in Graz provides expertise in aseptic production, a diverse portfolio of high-end products, a great variety of container options with flexible production configurations, and a comprehensive service package from first feasibility studies to approval strategies worldwide.

A focus lies on the production and distribution of medicines in prefilled syringes and also glass bottles, a strongly growing segment with clear advantages for healthcare professionals in terms of usability and safety. The plant operates in compliance with national, European and US FDA GMP regulations, supplying domestic and international markets through affiliate structures.

The Wilson, North Carolina plant is a state-of-the-art, highly automated manufacturing facility with a $100 million expansion investment running and is specialized in the formulation, syringe filling, and packaging of aseptic and terminally sterilized drug products and diluents with the advantage of being able to offer large-scale quantities and flexibility in the syringe portfolio and sizes. PFS drug products and diluents are produced on fully automated manufacturing, inspection, and packaging lines in a continuous process under controlled conditions. This highly automated and state-of-the-art manufacturing facility, half of which is dedicated to prefilled syringe production, has a unique capability and capacity to launch hundreds of millions of new and existing commercial PFS drug products including biologics, highly active compounds and products (maximum OEL = 0.1 µg/m3), and products that are sensitive to temperature, light, and/or oxygen.

We would love to learn more about your needs and challenges, how we can support you with bringing your next product filled in a syringe on the market. As a one-stop provider, we will support you with the complexity during the implementation with our experienced on-site teams. Once commercial, our two state-of-the art plants will be the perfect facility to partner for your product. Please get in touch with us at [email protected] and visit our website at https://cmo.fresenius-kabi.com.