Halle / Westfalen, Germany

Inside the highly sophisticated Halle/Westfalen manufacturing facility

MANUFACTURING SERVICES

The facility provides aseptic manufacturing of:

  • Vials
    - 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)
A fill operation at the Halle/Westfalen manufacturing facility

FACILITY INFORMATION

  • 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
An aerial view of the Halle/Westfalen manufacturing facility

ACHIEVEMENTS

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