Grand Island, USA
The Grand Island Production Unit is located just over ten miles away from Buffalo, NY, and a few minutes away from the spectacular Niagara Falls. Buffalo is in the Western New York region in the northeast of the US and is the second largest city in New York state. The Grand Island plant has an impressive 50-year manufacturing history with the last 12 of those years being under Fresenius Kabi ownership with significant investments of approximately USD 200 M within the last decade.
The plant currently ships approximately 200 million vials annually, embodying the company’s commitment to “Caring for Life” with each patient dose. Currently, the main markets are the US and Canada with an intention to expand to the European market. The vials shipped range in size from as small as 2 mL to as large as 100 mL and include mostly critical care and anesthetic and analgesic products, utilizing either aseptic processing technology or terminal sterilization. Heparin Sodium, in various strengths and formats, is the highest-volume product produced in Grand Island and is used to prevent and treat blood clots and clotting disorders in patients.
Today, the plant consists of two production facilities for manufacturing IV drugs and of one recently added facility dedicated to monobactam products filled in vials. The 193,725 ft2/17,998 m2 production facility that focuses on IV drugs features four open restricted-access barrier filling lines, one of which has lyophilization capability and two terminal sterilization lines. The other 94,500 ft2/8,779 m2 production facility focuses on IV drugs and features three isolator technology lines including lyophilization capability. Further, the fully automated monobactam facility in development contains 19,000 ft2/1,765 m2 of manufacturing space with the option to offer contract manufacturing services for antibiotics.
The site’s focuses include controlled substance production and logistics, lyophilization, and sterilization. Out of the eleven lyophilizers, five have automated loading systems and two of these are dedicated to monobactam production. The site is also home to three raining water terminal sterilizers and has investment plans for a fourth to increase capacities further.
With a cross-functional team of more than 800 employees across five shifts, the plant is constantly improving and advancing. Examples include the addition of larger tanks to increase formulation batch size, automatic cleaning processes for equipment, in-line depyrogenation tunnels, automated visual inspection recipes, and packaging serialization. The site has also assembled a team to implement electronic batch records to aid in the batch release process at the highest compliance levels.
We are committed to sustainable production, which is evident in the efforts of all three US plants to obtain ISO 14001:2015 (Environmental Management) certification, which is planned for 2020, and ISO 50001:2018 (Energy Management) certification, which is planned for 2021. As part of Fresenius Kabi’s responsible energy and environmental initiative, the Grand Island site implemented a strategy for waste reduction in processes and worked with internal and external experts to reduce power consumption, boost recycling, and invest in the wastewater treatment facility.
We are also demonstrating a fast scale-up of the life-saving drug Cisatracurium to combat symptoms of COVID-19 patients using ventilators. The Grand Island Engineering, Technology Transfer, and Production teams are working together to determine equipment, utilities, and process requirements for this new program. The team’s collaboration and passion are vital to advancing this product launch to save the lives of many COVID-19 patients.
The Grand Island 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!
Technologies:
- Lyophilization
- Aseptic liquid filling
- Terminal sterilization
Products:
- Oncologics
- Anti-infectives
- Anaesthetics
- Analgesics
- Critical care
- Schedule II & IV Controlled Drugs
Containers:
- Plastic vials (3 - 200 ml)
- Glass vials (2 - 200 ml)
Certificates:
- US-FDA
- Canada-Health Canada
- DEA
Markets:
- USA