Baxter Healthcare Corporation's BioPharma Solutions Business - Full Contract Service Capabilities

Customers depend on your product. You depend on an outsourcing partner who delivers it the product with quality, efficiency, and reliability. Baxter’s versatile, worldwide manufacturing resources give you the assurance you need to meet market demand, from form / fill / finish of small molecule parenterals to production of cytotoxics and biologics.

MEETING YOUR DEVELOPMENT, CLINICAL AND COMMERCIAL OUTSOURCING NEEDS

With more than 70 years in parenteral manufacturing behind us, we offer a wide spectrum of contract services, providing reliable supply, scientific expertise and bottom line results to meet your development, clinical and commercial outsourcing needs. Our range of contract services includes:

• Syringe filling, cartridge filling, vial filling and lyophilization in Bloomingtom, IN, USA
• Cytotoxic manufacturing in Halle, Germany
• Monoclonal antibodies and recombinant proteins in California, USA

SYRINGE/CARTRIDGE/VIAL FILLING AND LYOPHILIZATION

Baxter’s Bloomington facility is a fully dedicated pharmaceutical contract service supplier with state-of-the-art manufacturing capabilities. We can provide a wise range of contract manufacturing services including syringe filling, cartridge filling, vial filling and lyophilization to a full spectrum of analytical and microbiological resources.

Manufacturing on both clinical and commercial scales, Baxter can produce human and veterinary products encompassing small molecules, proteins/peptides, vaccines and other biotech pharmaceuticals.

CYTOTOXIC MANUFACTURING

Baxter offers the advantage of providing integrated cytotoxic contract services from a single source. In our German facilities, we can take you from scale-up to commercial production. Our state-of-the-art facility features advanced aseptic processing using barrier isolator technology.

Our cytotoxic manufacturing capabilities include:

• Lyophilization – with recently expanded cytotoxic capabilities to meet increased demand
• Aseptic liquid fill of vials
• Dry powder vial filling
• Sterile crystallization
• Integrated support services designed to help speed your product to market, including stability storage, transfer and analytical services

MONOCLONAL ANTIBODIES AND RECOMBINANT PROTEINS

Baxter has over 15 years of experience in developing and manufacturing monoclonal antibodies and recombinant proteins. We offer comprehensive process development and manufacturing packages that can be customized to meet our clients’ specific needs, including:

• Cell-line development
• Cell banking
• Cell-culture process development
• Purification process development
• Protein characterization
• Yield improvement
• Pilot, clinical, and commercial-scale manufacturing
• Formulation development
• Fill and finish
• Quality assurance, quality control, validation and regulatory support