Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY DESCRIPTION

Fresenius Kabi Product Partnering is the contract manufacturing platform of Fresenius Kabi, providing sponsors access to group wide resources on sterile liquids as well as medical devices development and manufacture. Many years of experience in performing contract development and productions for pharmaceutical multinationals, regionally operating and start-up companies have created an organization that not only understands its sponsor’s needs, but has adopted these as a basis for its operations and its approach in executing projects and
toll manufacturing.

COMPANY BACKGROUND

Key Personnel

Key Personnel:
Geral Hofer, Senior Director Contract Manufacturing
Anton Gerdenitsch, Director Contract Manufacturing
Uwel Woelk, Director Contract Manufacturing
Stefan Vogt, Sales manager Medical Devices

Company Focus

FACILITIES

Fresenius Kabi Product Partnering covers over 20 manufacturing sites of Fresenius Kabi worldwide. All sites, specialized in sterile operations, apply strict Quality Standards as laid down in the corporate guidelines, and licenses are present from worldwide regulatory authorities including the US-FDA. The main services offered are development of robust formulations that can easily be scaled up to commercial size and manufacturing of sterile liquids as well as development and production of medical devices at a scale compliant to the requirements and dynamics of our sponsor’s product. New products are evaluated on basis of a “Best Fit Analysis”, which includes sponsor requirements, product specifications and in-house production technology. Dedicated project teams, working in close collaboration with our sponsor, minimize the time
to market.

SERVICES & CAPABILITIES

Manufacture of clinical trial medication and
commercial products
Fill/finish of ampoules (glass and plastic), bottles (glass and plastic), IV-bags (mini, standard and multi-chamber), vials (glass and plastic), pre-filled syringes (glass and plastic) and specialty devices
Aseptic processing and terminal sterilization
Solutions and disperse systems
Formulation development of solutions and disperse systems next to container design
Development and Construction of medicine-technical disposables for infusion therapy, enteral therapy and subcutaneous application
Development including O-series prototype manufacture to fully or partially automatic mass production
Packaging, sterilization and final inspection of finished products by QA
Full analytical, microbiological, pharmaceutical and
regulatory assistance
Global and local supply
Integrated supply chain
World wide shipping
Support throughout the life cycle of the products