Baxter Biopharma Solutions - Full Contract Service Capabilities and Manufacturing Resources

Baxter's BioPharma Solutions business provides manufacturing resources and contract manufacturing services. As the winner of the Frost & Sullivan 2008 North American Contract Manufacturing Customer Service Leadership of the Year Award, Baxter is committed to providing service with a passionate focus on efficiency and results.

Customers depend on your product. You depend on an outsourcing partner who delivers it 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 the production of cytotoxics and biologics.

Fill/finish production capabilities

Parenteral manufacturing is a delicate balance of expertise, reliable supply and technology. As a dedicated CMO with over 20 years of experience devoted to our customers’ clinical and commercial success, we understand what it takes to deliver your products at a global level.

Parenteral manufacturing services

Baxter brings together state-of-the-art B2B manufacturing for all of your parenteral needs:

• Global leadership in SCF prefilled syringes
• Dedicated biologic capabilities
• Industry-leading lyophilization and liquid vial filling
• Seamless cytotoxic services
• Cartridges
• Packaging

You can count on Baxter, a proven CMO provider, for best-in-class parenteral outsourcing solutions that deliver the confidence, speed and cost efficiency you need in the competitive parenterals market.

Lyophilization and filling lines for syringes, vials and cartridges

Our investment in state-of-the-art biologic manufacturing resources provides an ideal environment for your molecule's transition to commercial production.

Innovative technologies integrated into our newest lyophilization and filling lines for syringes, vials and cartridges are specifically designed to protect your biologic's integrity and optimize yield of costly API. Advantages include:

• Allows 100% in-line, non-destructive check weighing
• Advanced cold-chain filling maintains ideal molecule temperature from tank to filling head and accumulation table to automated lyophilization load/unload
• Dual filling technologies – peristaltic pump or sensor-based time-pressure filling reduces stress and prevents shearing
• High-yield process design

Cytotoxic capabilities

At our newly-expanded cytotoxic manufacturing facility in Halle, Germany, all of your cytotoxic parenteral needs are handled under one roof, which allows us to create highly efficient processing solutions to fit your compound. A dedicated cytotoxic focus helps ensure capacity and flexibility-critical ingredients for maintaining reliable product supply.

Lyophilization and filling capabilities include:

• Liquid and dry-powder filling
• Clinical and commercial-scale lyophilizers
• Sterile crystallization
• Lyo cycle development

Integrated support services designed to help speed your product to market include:

• Stability storage, validation and documentation
• Technology transfer
• Analytical and microbiological services
• Packaging/kitting

Pharmaceutical suspensions and freeze-dried dosage forms development

Our scientists are highly skilled in the development of solutions, suspensions and freeze-dried dosage forms, which help optimize product quality throughout manufacturing. Baxter’s Lyophilization Center of Excellence provides industry-leading solutions for cycle optimization and manufacturing efficiency.

Commercial/regulatory support

A strong compliance record with local and worldwide environmental health and safety (EHS) standards streamlines your path to market while helping to maintain a continuous product supply:

• Manufacturing practices certified to ISO 14001
• Quality cytotoxic manufacturing provided to more than 90 countries around the world
• Full compliance with global standards including US FDA, EU GMP and Japanese standards
• More than 20 years of experience with the US market and the FDA approval process