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Formulation Technologies

With decades of experience, our team specializes in the development of various types of sterile pharmarceuticals mainly for parenteral administration.

    • Aqueous solutions (aseptic or terminally sterilized)
    • Emulsions
    • Liposomal formulations
    • Suspensions
    • Lyophilisates 

 


 

 

In the Spotlight

 

At FKPP, we can help reduce the element of chance with a special formulation development center at the Fresenius Kabi site in Graz, Austria. The center is responsible for iv drug development, formulation, manufacturing of clinical batches, and dossier compilation, and is part of our global R&D division.

 

The facility includes both a galenics department, which can manufacture small-scale non-GMP batches, and a pilot plant, which can make GMP and clinical batches from 5 L up to 1000 L. The combination enables very high quality development work from bench to clinical scale. In the galenics department, we can start with quantities of a few milliliters, allowing us to test multiple formulations for expensive drugs. Later in the development process, bigger batches of the most promising formulations are manufactured and put on accelerated stability, to study all aspects of chemical and physical influences on these formulations. When a promising formulation of the drug product has been worked out, the pilot plant is used to manufacture clinical batches and registration batches under cGMP conditions. These batches are put on ICH stability programs to deliver all the necessary data for the dossier which is finally submitted to the authorities.

 

The range of formulation types we can handle includes simple sterile aqueous solutions, highly sophisticated formulation systems like emulsions and liposomes, and highly potent powder products. These products can be filled in glass vials and bottles (from 5 mL up to 1000 mL), plastic bags (from 50 mL to 1000 mL), and pre-filled syringes (from 1 mL to 50 mL). All these products have to be sterile at the point of use and we have a versatile hot water spraying autoclave, which we can use to find a sterilization process compatible with the specific product.

 

When it comes to testing the full spectrum of common analytical methods can be offered (e.g. HPLC, GC). But the center has also particular competence in analytical methods for emulsions and liposomes. Very good relationships and cooperation with external labs help to circumvent capacity constraints and provide access to highly sophisticated methods like NMR, electron microscopy, and mass spectroscopy. All these development activities are carried out by a highly motivated team of lab technicians and scientists who have long experience in developing sterile drug formulations.

 

We have proven our flexibility in responding to customer needs many times, e.g. by installing new technology for specific projects. A cooperation with us could give your product a head start in its clinical trials.