Based on our aim to be a full-service provider to our partners, we have built a large portfolio of supporting activities that facilitate the development of formulations and processes and manufacturing of sterile injectables and medical devices in an efficient and cost-effective manner. We strive to streamline your supply chain by being your experienced, single-source partner.
Procurement of Material
We have experience in sourcing all the materials needed for manufacturing your sterile products according to your specifications from suppliers that we have audited and qualified in our vendor programs.
Fresenius Kabi Contract Manufacturing has the scientific, regulatory, and product development expertise to support a vast range of projects.
We provide full QC support - physical, chemical, and microbiological - for starting materials, finished products, and in-process control. In-house expertise is available to develop and validate new analytical methods and to import and modify existing methods.
Process Development and Optimization
The validity of clinical trials depends crucially on being able to safely apply the trial results to the commercial version of the drug. The manufacturing process used to make the drug used in the trial must be stable and scalable. Fresenius Kabi Contract Manufacturing offers first-class support in developing production processes for clinical trial drugs that avoid problems in the subsequent transfer to commercial scale. Drawing on Fresenius Kabi‘s decades-long track record of successful development of sterile pharmaceuticals, we provide made-to-measure solutions from galenic development to implementation of a stable manufacturing process, scale-up, and finally manufacturing of GMP batches for clinical and commercial use.
Our regulatory departments have experience in supporting submissions of our partners' sterile products. CMC parts of the files are drafted in the CTD standard, guidance is offered based on knowledge of the relevant regulatory regimes worldwide, and interaction with the regulatory bodies side by side with you, our partner, is our day-to-day business.
Technical Transfer and Validation
Fresenius Kabi Contract Manufacturing can execute technical transfers to one of the plants in its global network, thus ensuring effective and prompt results. During technical transfers, process validation must be performed in accordance with regulatory and cGMP guidelines to establish a reliable commercial supply. Freseniu Kabi Contract Manufacturing offers a vast range of services: we can perform process validation with critical parameters and validation of analytical assay according to our partners requirements and ICH conditions.
Each of our plants has qualified in-house climate chambers and can do ICH-compliant stability studies, using carefully set conditions depending on product characteristics, regulatory requirements and the desired shelf life.
All our manufacturing sites have conditioned warehousing spaces. Storage of all materials is possible at ambient temperature (15°C-25°C) and at 2°C-8°C. Worldwide shipping and distribution services are available on demand and are used by a number of partners.
Product Life-Cycle Management
As a full-service provider we support our partners throughout all stages of the product life cycle. We contribute at clinical trial levels, secure supply during growth of a product, and offer additional services during the later stages of the life cycle.
Packaging and labeling
We offer expertise in cGMP primary and secondary packaging for sterile dosage forms and medical devices. Our knowledge of packaging materials, as well as the possibility to test them in-house, ensure the development of a feasible packaging that can preserve the properties of our partners' products. Our experienced team can provide advice in component specification, container-closure-integrity testing, stability and safety.