Melrose Park, USA
Do you have a developed parenteral injectable product in glass vials (2–200 mL) and are you looking for a high throughput facility to partner with for Phase 3 and/or for commercialization? If so, then the brand-new Fresenius Kabi Melrose Park Production Unit is for you. We are located in a general industrial area in the outskirts of Chicago, five miles away from O’Hare International Airport. The facility became a licensed pharmaceutical plant in 1984, has more than 12 years history within Fresenius Kabi, and currently produces a wide range (250 finished products) of parenteral injectable medicines for the treatment of critically and chronically ill patients.
In 2016, Fresenius Kabi announced that it would invest approximately USD 250 M over ten years to expand the company’s Melrose Park, Illinois, production unit. The expansion was built as a stand-alone building with separate utilities and linked in 2020 to the existing 125,000 ft²/11,613 m2 site, with a total floor space of 430,000 ft²/40,000 m2 . The new facility is equipped with a state-of-the-art urban manufacturing campus, fully automated aseptic filling lines, and sophisticated isolator technology, as well as expanded lyophilization capabilities and formulation areas.
A total of five integrated aseptic filling lines and four lyophilizers with automated loading are being installed in the expansion, including one cytotoxic line, one high-potency and hormone line (maximum OEL = 0.2 µg/m3), and three general product lines to increase manufacturing capacities by more than 100 million vials by 2026. Today, six aseptic filling lines, six lyophilizers, and one terminal sterilizer in the existing site produce more than 160 million vials each year for distribution in the US and Canada.
We offer also fill and finish services for highly potent products in a multiproduct facility using effective separation with smart HVAC and architecture design and new disposable single-use system technologies with fully disposable and/or dedicated product contact parts for the reduced risk of cross contamination. Additionally, we offer technologies required for filling advanced complex parenterals such as emulsion processing, cold filling, oxygen reduction, metal–sensitive, and other sophisticated technologies.
The site is also home to GMP-compliant semiautomated and automated inspection processes and five packaging lines, two of which are fully automated. All are installed with serialization and aggregation (track-and-trace) equipment to meet DSCSA requirements.
The expansion project will be completed to meet the latest quality requirements for global supply. We are committed to sustainable production – all US plants aim to obtain ISO 14001:2015 (Environmental Management) certification and ISO 50001:2018 (Energy Management) certification, which is planned for 2021.
The Melrose Park site looks forward to partnering with you for your contract manufacturing needs. We embrace the opportunity to learn and grow our technical capabilities together. Our team is eager to make a difference in the lives of our customers and their patients!
- Aseptic liquid filling
- Terminal sterilization
- Glass vials (2 - 200 ml)
- Canada-Health Canada