The facility provides aseptic manufacturing of:
- Lyophilizates 2 mL - 100 mL
- Liquid Vials 2 mL - 100 mL
- Powder filled Vials 6 mL - 100 mL
- Sterile crystallization Polythene bags (1 kg - 5 kg)
- SafeBridge certified
- Qualified cold chain storage: -70°C/-20°C/2-8°C/15-25°C
- Sterile crystallization of cytotoxic APIs
- Meets US, EU, and JP regulatory standards
- Environmental Health and Safety Certification is according to ISO 14001
The facility has been noted by both clients and the industry. For example:
- A client raved about the facility: "Outstanding site that is the gold standard."
- FOYA (Facility of the Year) 2016 Winner, Category Award for Operational Excellence.
- Winner of 2009 European Outsourcing Award "Best Tech Transfer/Scale-Up".
- Certified by SafeBridge doing both parenteral drug substance synthesis and parenteral drug product manufacturing and testing.
By offering a full complement of services in one location to support oncology drug production needs, we are able to meet clients’ growing needs for cytotoxic manufacturing in a single location, including early-to-late stage support to fully engage and service our clients throughout the lifecycle of their products.
Plant Manager, BioPharma Solutions’ Halle/Westfalen, Germany, facility