Key Personnel

Gerald Hofer, Senior Director Contract Manufacturing

Stefan Vogt, Vice President Marketing & Sales Contract Manufacturing, Medical Devices

Who We Are

Fresenius Kabi Product Partnering is a global leader in the contract development and filling and finishing of parenterals, as well as the manufacture of sterile disposable products. Being part of Fresenius Kabi, we offer our customers access to more than 20 innovation and manufacturing centres. Unparalleled production capabilities, outstanding quality compliance and an excellent track record in contract manufacturing have made Fresenius Kabi Product Partnering the supplier of choice for an impressive number of pharmaceutical companies.

Services Offered

Development Expertise

Fresenius Kabi Product Partnering puts decades of development experience and know-how at Fresenius Kabi to work for its customers. Our expertise includes:

• Development of formulations (solutions, emulsions and novel disperse systems)
• Development and engineering of medicine-technical disposables for infusion therapy, enteral therapy and subcutaneous application
• Design, selection and qualification of primary and secondary containers
• Set-up of QC methodology
• Development including O-series prototype manufacture to fully or partially automatic mass production
• Clinical manufacturing
• Drug improvement through polymer conjugation (HESylation) and novel disperse formulation systems (liposomes and mixed micelles, for example)

Toll Manufacturing

Fresenius Kabi Product Partnering covers over 20 Fresenius Kabi manufacturing facilities operated in strict conformity with international quality standards (FDA-GMP, EU-GMP, WHO-GMP, and medical device regulations). New products are evaluated by means of an initial feasibility study in which the best fit between client (location and required services), product (process requirements, product size and markets) and facility (location, on-site technology and support toolbox) is determined. The start-up of manufacturing is supported by a dedicated project team and time-to-market is minimised by an efficient development and qualification programme in which validations, stability studies, regulatory support and all other elements relevant to a specific product are brought together in a single project plan established in close co-operation with the customer. Major toll manufacturing services include:

• Filling and finishing of IV-bags (large and mini bags), bottles (glass and plastic), vials (glass and plastic), ampoules (glass and plastic), pre-filled syringes, customised containers
• Aseptic processing, terminal sterilization and lyophilisation
• Processing of solutions and disperse systems such as emulsions and liposomes
• Packaging, sterilisation and final inspection of finished products by QA
• Full analytical, microbiological, pharmaceutical and regulatory assistance
• Worldwide shipping
• Optimal logistics through a manufacturing presence on all continents

Markets and Approach

The business approach of Fresenius Kabi Product Partnering is to provide our customers integral support throughout the life cycle of their sterile products. From the early stages through to full commercial scale, covering development and filling and finishing, supporting worldwide demands.

A focus on continuous improvement and innovation keeps the product tailored to customer requirements, market conditions and market needs at all times.