DEVELOPMENT
Over decades of producing and handling sterile fluids, we have built up broad and in-depth expertise in designing formulations, in selecting and qualifying containers and in implementing and scaling up manufacturing processes. We understand what your users need, and we know how to design convenient and cost-effective delivery systems for them.
At Fresenius Kabi Product Partnering, we can support our partners through the stages of product development. For this purpose we work with our development units in Fresenius Kabi. We form a suitable development group within our organization and a responsible person (project leader) will be assigned to your project.
Pharmaceutical Development - Formulation
At 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 containing hydrophilic and/or lipophilic ingredients. 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.
Formulation development usually starts with a feasibility study to identify the various options. The selected formulation strategy is then challenged and optimized by applying stress conditions in order to obtain a robust formulation. This enables a smooth transfer to in-house manufacturing of clinical trial medication and commercial products.
Pharmaceutical Development - Container Closure System
Different products and/or markets require different containers. It has become more and more critical to choose the right container if a product is to be widely accepted on the market. 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.
Our standard range of primary containers includes ampoules, vials, bottles (all glass or plastic), pre-filled syringes (glass or plastic), single-chamber flexible bags (non-PVC), multi-chamber bags, blow-fill-seal containers (polyethylene and polypropylene), and several specialty devices such as cassettes and cartridges.
Process Implementation
Before we begin to run new processes or manufacture a new product, we do a feasibility study. This will survey everything relevant to the process, so that technical issues, support services required, manufacturing site competencies, and risk analyses are properly assessed in advance. With the results of the feasibility evaluation, we make a proposal to our partner. If this meets with the requirements, we proceed to a detailed project plan and appoint a project team in the relevant plant, who will see the project through from beginning to end according to the agreed timelines.
Scale-up and Manufacturing Site Transfer
During 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.