Baxter BioPharma Solutions Sterile Injectables Contract Manufacturing
Baxter’s contract manufacturing organisation (CMO) BioPharma Solutions offers form / fill / finish services for injectables.
With a successful combination of strong collaborations and 85 years of injectable drug experience, the company provides manufacturing services for a wide range of pharmaceutical drugs, including for the areas of oncology, biologics, antibody-drug conjugates (ADC), and vaccines. These are applicable for a variety of sterile dosage forms, including pre-filled syringes, cartridges, diluents for reconstitution, prefilled syringes, and lyophilised / liquid vials.
Baxter BioPharma Solutions helps clients with challenges in clinical supply, formulation, risk mitigation, patent expiry, scale-up of production, and addresses rises and falls in market demand.
Each solution is tailored specifically for each individual case, meeting clinical, commercial, traditional, and complex issues in sterile manufacturing.
Sterile current good manufacturing practice (cGMP) production facilities
With more than 50 manufacturing facilities worldwide, Baxter BioPharma’s award-winning current good manufacturing practice (cGMP) production facilities provide unique, high-value collaboration opportunities. The company’s extensive global network utilizes a key systemic approach to cGMP manufacturing to share efficiencies and expertise.
Baxter BioPharma Solutions’ manufacturing units have recently won 2016 Facility of the Year (FOYA) award for Operational Excellence; 2012, 2013, 2015, 2016, and 2017 CMO Leadership Awards from Life Science Leader magazine; and the 2010, 2011, 2012, and 2015 Best Contract Manufacturing Organization at the Vaccine Industry Excellence Awards.
Syringe, cartridge, and vial filling for sterile products
Based in Bloomington in Indiana, Baxter BioPharma Solutions’ state-of-the-art 600,000ft² campus is one of the largest contract manufacturers of sterile products in North America. This facility helps clients develop and manufacture quality products and packaging, with particular expertise in regulation and lyophilisation.
Contract manufacturing of oncology products
Baxter BioPharma Solutions’ facility in Halle in Germany focuses on the manufacturing of cytotoxic and highly potent drugs. With more than 60 years of experience, the facility is certified by Safebridge and provides clinical and commercial production, with integrated technologies and services.
The recently expanded facility is dedicated to contract manufacturing of oncology products, such as cytotoxic, highly potent compounds, and ADCs. It received the FOYA in 2016 for Operational Excellence. Capabilities include liquid and dry powder filling, sterile crystallisation, disperse systems, clinical and commercial-scale lyophilisers, and flexible compounding areas.
Formulation and process development expertise with a wide variety of drug categories
Helping tackle technical challenges such as technology transfer and formulation, process, and analytical development, Baxter BioPharma Solutions’ teams help clients develop freeze-fried dosage forms, solutions, and suspensions for full optimisation of drug products throughout manufacturing.
The company provides expertise in optimisation and development in lyophilisation, converting drugs from a lyophilised to a liquid state through reformulation, converting drugs from vial to prefilled syringe form, analysing extractables and leachables, and selecting components, including flexible containers, syringes, vials, and stoppers.
Baxter BioPharma Solutions’ scientific team provides a large amount of industry experience across a wide variety of drug categories, including vaccines (adjuvant, conjugate), biologics (monoclonal antibodies, therapeutic proteins), cytotoxics, highly potent compounds, and antibody-drug conjugates (ADC).
Lyophilization Center of Excellence
Increasing stability for injectables and improving lyophilisation cycle times are vital parts of parenteral product development. With this optimisation, Baxter BioPharma Solutions formed the Lyophilization Center of Excellence to act as a resource centre for the production of high-quality freeze-drying.
Scientists and educators Dr Steven Nail and Wendy Saffel-Clemmer lead Baxter’s development team to assist with the modification and reformulations that optimise lyophilised products. The company offers:
- Cost-effective and targeted lab-to-product correlation for optimum product manufacturing
- State-of-the-art equipment for the detection of aggregation and other stability problems
- Automatic loading and unloading of lyophilisers to minimise microbial exposure and handling
- Top analytical methods for protein biophysical characterisation and measurement of aggregates
- Capillary electrophoresis expertise, including capillary isoelectric focusing (cIEF) and capillary gel electrophoresis (cGE)
- Four research freeze-dryers for development of cycles for future clinical manufacture
- Proven scientific approach to cycle development, verses traditional methods of trial-and-error
Products and Services
Parenteral cytotoxic agents are sensitive drugs to handle and produce.
Prefilled Syringe Filling
BioPharma Solutions, a global contract manufacturing leader in prefilled syringe fill-finish, provides clinical through high-volume commercial sterile manufacturing.
Complete Support For Antibody-Drug Conjugates (ADCs)
Baxter's BioPharma Solutions business (BPS) and SAFC (a business unit of Sigma Aldrich) are offering a combined approach for ADC requirements to simplify supply chain and provide comprehensive, coordinated and collaborative services for the development, manufacturing, and testing of bulk drug substance and drug product.
Syringe, Cartridge, Lyo, and Liquid Vial Filling in Bloomington, Indiana
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 600,000ft² campus.
Lyophilization Center of Excellence
Optimising lyophilisation cycle times and improving stability for complex injectables is a critical component of parenteral product development.
The Scientific Path to Cycle Development: Optimizing the Lyophilization Process
Management of medication delivery through lyophilization, freeze-drying, is a crucial enabling process technology for many important parenteral drugs.
Process Development for Lyophilised Products
A common approach to process development for lyophilised products is to thermally charactertise the solution formulation that should not be exceeded during primary drying. This is conducted using differential scanning calorimetry (DSC) and freeze-dry microscopy (FDM).
A Clinical Perspective on IV Medication Delivery
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists.
Best Practices in Formulation and Lyophilization Development: Proteins, monoclonal Antibodies (mAb), and Antibody Drug Conjugates (ADC)
The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications and free of extrinsic and intrinsic particles.
Pharmaceutical Development for ADCs
Formulation, process and analytical development for antibody-drug conjugates (ADCs) can be complex.
Jinyu Bio-technology Research Facility, Kansas
Fresenius Kabi’s Pharmaceutical Manufacturing Facility Expansion, Melrose Park, Illinois
Baxalta Biologics Facility, Georgia
Baxter’s BioPharma Solutions facility in Bloomington, Indiana, was recognised for the fifth time as the Best Contract Manufacturing Organization at the annual Vaccine Industry Excellence (ViE) Awards, held during the 2017 World Vaccine Congress in Washington, DC.Read more
Baxter BioPharma Solutions Wins 2016 ISPE Facility of the Year Award (FOYA) in the Operational Excellence Category
Baxter's BioPharma Solutions business is pleased to announce that the company's oncology manufacturing facility expansion in Halle, Germany is a winner of the 2016 Facility of the Year Award (FOYA) in the category of Operational Excellence.Read more
Baxter's BioPharma Solutions and Sigma-Aldrich Corporation's (SAFC) commercial custom manufacturing services business unit have established a collaborative manufacturing agreement.Read more
Pharmaceutical / biopharmaceutical clients of the contract manufacturing organisation (CMO) will be able to leverage BPS's expanded Drug Master File and choose a custom-fill volume and labelling, while streamlining development work and process validation batches, eliminating capital equipment costs. This can considerably reduce time to market.Read more