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Development

 

Pharmaceutical Development - Formulation

FILL INAt any stage of your product's life cycle, you can rely on us for help with development or modification of the product formulation. Our experience and expertise covers solutions, emulsions and suspensions. Our proprietary emulsion technology could be the route to a robust formulation of your lipophilic substance. Our HESylation technology offers a way to improve delivery and efficacy of therapeutic proteins and small-molecule drugs.
 

Pharmaceutical Development - Container Closure System

FILL INDifferent products and/or markets require different containers. Fresenius Kabi Product Partnering offers a complete range of container types. We assist you in finding the right container and closure system, and can also customize our container closure systems to suit your requirements (Link: Container Selection).
 

Process Implementation

FILL INBefore manufacturing a new product or implementing new processes on a commercial scale, we first start with a feasibility study. This strategy will make sure to survey all relevant aspects of the process in advance. Such a study aims to assess possible technical issues, to identify required support services, to take the competencies of the manufacturing site into account and to carry out a risk analyses. With the results of the feasibility evaluation in mind, we make a proposal to our partner. If this meets our partner’s requirements, we proceed to a detailed project plan and appoint a project team in the relevant plant managing the project from beginning to end according to agreed timelines.
 

Scale-up and Manufacturing Site Transfer

FILL INDuring the late development phase of the product, or if we need to transfer a product to a different manufacturing site, we draw up a project plan to specify and set up the commercial manufacturing process. This uses available data from initial formulation / development work and production of preclinical and early-stage batches. The plan is a detailed description of the route to a cost-efficient process, compliant with the relevant regulatory regimes. The implementation of this process is fully supported by in-house engineering, quality assurance, validation and regulatory staff to enable and prepare for pre-approval inspections as part of the regulatory submission.