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.
PFS are also a system of choice for cost-intensive drugs by optimizing product yield. Fresenius Kabi Contract Manufacturing offers services and expertise for manufacturing products in PFS and has the flexibility to accommodate the needs of your product.
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.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance