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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Worldwide Facilities

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Expansive Network.

With more than 50 manufacturing facilities across six continents, Baxter's global presence provides opportunities for unique sterile contract manufacturing collaborations to provide the most value for our partners. The power of an extensive global network lies in the coordination of, and efficiencies resulting from, a systemic approach to cGMP manufacturing. Our manufacturing network provides the possibilities of tailor-made solutions. Best practices and common lean principles are shared so that we continuously build upon our strong culture of operational excellence. In fact, several of Baxter's facilities have been awarded the distinguished Shingo Prize for Operational Excellence.

Baxter has manufacturing sites across the globe in support of a diverse portfolio of delivery systems and manufacturing solutions.

1. Bloomington, Indiana, USA

Overview

BioPharma Solutions' facility in Bloomington. Indiana, USA.is one of the largest contract manufacturers of sterile products in North America, with a state-of-the-art 600,000-square-foot campus. As a full-service contract manufacturer, our Bloomington facility serves client needs with clinical development through commercial launch.View More

These include manufacturing, packaging, quality systems, experience with worldwide regulatory agencies and lyophilization expertise with our Lyophilization Center of Excellence.

Manufacturing Services

The facility provides aseptic formulation, filling and finishing services for:

  • Prefilled Syringes 0.5 mL - 20 mL
    - Diluents for Reconstitution
  • Liquid Vials 2 mL - 100 mL
  • Lyophilized Vials 2 mL - 50 mL
  • Cartridges 1 - 3 mL

Facility Information

BioPharma Solutions' ISPE award-winning $100 million expansion of the Bloomington campus in 2006 provided additional syringe and vial-filling capacity. We offer:

  • Production capacity
  • Warehouse capacity including cold storage
  • Laboratory area

Achievements

Well-recognized in the industry, as noted by numerous accolades:

  • 4-time "Best Contract Manufacturing Organization", ViE Awards, 2015, 2010-2012
  • Winner of Frost & Sullivan's 2008 North American Customer Service Leadership of the Year Award
  • The International Society for Pharmaceutical Engineering (ISPE) recognized BioPharma Solutions' with the 2006 Facility of the Year Award

2. Halle / Westfalen, Germany

Overview

Recognized as a world-class manufacturer of cytotoxic and highly potent drugs with over 60 years of experience. BioPharma Solutions' facility in Halle/Westfalen, Germany offers dedicated clinical through commercial production with integrated technologies and services. The state-of-the-art facility is equipped with barrier technology.View More

Manufacturing Services

The facility provides aseptic manufacturing of:

  • Vials
    • - Lyophilizates 2 mL - 100 mL
    • - Liquid Vials 2 mL - 200 mL
    • - Powder filled Vials 6 mL - 100 mL
  • Ampoules 1 mL - 10 mL
  • Sterile crystallization Polythene bags (1 kg - 5 kg)

Facility Information

Facility Specifications:

  • SafeBridge certified
  • Qualified cold chain storage: -70oC/-20oC/2-8oC/15-25oC
  • Sterile crystallization of cytotoxic APIs
  • Meets FDA, JP, and EU regulatory Standards
  • Environmental Health and Safety Certification is according to ISO 14001

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"
  • The only company worldwide with facilities certified by SafeBridge doing both parenteral drug substance synthesis and parenteral drug product manufacturing and testing

3. Round Lake, Illinois, USA

Overview

Baxter is the worlds leading provider of manufacturer prepared IV solutions, and our Round Lake facility is a best-in-class aseptic solution manufacturer. Baxter's portfolio of premixed drugs is the broadest in the industry. Our team has decades of experience in parenterals development, manufacturing, and partnering.View More

Parental delivery systems, such as ready-to-use premixed drugs manufactured in "...our Round Lake facility,...", provide an opportunity to differentiate your product and move patient care forward.

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"Our considerable experience and understanding of partnering, whether it be commercial scale, development, or start-up projects, translates into speed to market, reliability, and confidence for our clients."

Plant Manager, BioPharma Solutions’ Bloomington, Indiana, facility

"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

"Combining our innovation in disposable systems with manufacturing capabilities, we offer clients a seamless integration of process development and manufacturing capacity. We are committed collaborators in our client's development programs."

Plant Manager, BioPharma Solutions’ Hayward, California, facility