Fresenius Product Partnering - Contract Development and Manufacture of Sterile Fluids

Fresenius Product Partnering is the contract manufacturing platform of Fresenius Kabi, and provides easy access to company-wide resources on sterile fluids development and manufacture. The company has more than 18 manufacturing facilities worldwide and enjoys partnerships developing and manufacturing sterile fluids with top-tier pharmaceutical multinationals as well as start-ups and biotech companies.

Fresenius Product Partnering understands client and product-specific processes and procedures in contract manufacture, contract development, contract filling and contract packaging.

CONTRACT MANUFACTURING AND DEVELOPMENT – STERILE FLUID SOLUTIONS

Fresenius Product Partnering's manufacturing capabilities span the fill/finish of small and large volume sterile fluid solutions and emulsions. These are processed aseptically or terminally sterilized. Production infrastructure supports manufacturing at pilot scale through to full-size commercial scale for world markets. Fresenius Product Partnering's expertise covers the handling of potent active pharmaceutical ingredients, biologics and recombinant proteins.

Increasingly, the characteristics of the primary container are a critical issue in launching sterile fluid products successfully. Container characteristics are also important in establishing and maintaining market share throughout the life cycle of the product. Fresenius Product Partnering has the flexibility to incorporate clients’ specific demands on container configuration, and has the expertise to advise on the possibilities of delivery systems. The standard range of primary containers includes:

• Ampoules (glass or plastic): 1mL - 20mL
• Vials (glass or plastic): 1mL - 100mL
• Bottles (glass or plastic): 50mL - 1,000mL
• IV-bags (PVC or non-PVC): 40mL - 5,000mL
• Multi-chamber bags (non-PVC): 100mL - 5,000mL
• Speciality devices (various materials) 1mL - 200L

In addition to processing the standard range of containers, the company support clients in developing and processing containers with customized specifications and in a product/client specific configuration.

MANUFACTURING QUALITY AND COMPLIANCE

Quality standards and procedures are laid down in the Fresenius Product Partnering corporate guidelines, and are operated in compliance with cGMP and GcLP. These standards ensure sterile pharmaceutical fluids are developed and manufactured safely and efficiently.

Regulatory licenses for pharmaceutical products and medical devices, in addition to national approvals, cover FDA, PIC and TÜV notified bodies.

STERILE FLUIDS APPLICATIONS

Fresenius Product Partnering contract manufacture a large range of products for therapeutic applications. These include:

• Blood volume expanders
• Anaesthetics
• Antibiotics
• Antivirals
• Organ preservation solutions
• Contrast media

The only common denominator between these products is that they are sterile. The partners of Fresenius Product Partnering chose the company to contract manufacture their sterile fluid products due to their proven excellence in approach and performance.

CONTRACT MANUFACTURE SERVICE PROVISION

Fresenius Product Partnering aim to be a full service provider to their partners. For this reason, the company has built a large portfolio of activities which allow them to help at all stages of the product life cycle, including:

• Facilitating development of formulations
• Implementing processes
• Procuring materials
• Manufacturing products efficiently and cost-effectively
• Distribution
• Storage
• Stability testing

QUALITY CONTROL LABORATORY

The company provide full quality control support for starting materials, finished sterile products and all stages in between. This support includes physical, chemical and microbiological quality. In-house expertise is available to develop new analytical methods and to enhance existing methods. As new products become viable for clinical trials, full validation of the analytical procedures is performed.

REGULATORY AFFAIRS

The company's regulatory department has substantial experience in supporting global submissions of partner products. In collaboration with the development department, the CMC parts of the files are composed efficiently to assure quick entry to the market.

During contract development of sterile research products, regulatory staff interacts with the project team offering guidance and recommendations based on knowledge of the regulatory regime, including FDA requirements. For commercial manufacture, regulatory assistance is available to support worldwide submissions, including INDs and NDAs.

STABILITY STUDIES

ICH stability studies are performed and executed under carefully set conditions depending on the sterile product characteristics, regulatory requirements and desired shelf life.

MANUFACTURING LOGISTICS

Fresenius Product Partnering's manufacturing sites have conditioned warehouse space. Storage of active ingredients, excipients, packaging materials, intermediates and final product is possible at ambient temperature (15°C to 25°C), 2°C to 8°C, or -30°C. Worldwide shipping and distribution services are available for contract manufacture and development projects, and are currently exercised for a number of the company's partners.