Clinical Trials

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 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 sterile injectable capabilities include formulation, process development and manufacturing of sterile injectable drug products at scales suitable for clinical trials to large global commercial supply. Our highly trained and experienced scientists will collaborate with you to work out a development strategy that will lead to a stable product formulation.

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Depending on the critical quality attributes of your substance, we can offer one of the following formulation types:

  • Aqueous Solution       
  • Emulsion
  • Liposomal Formulation
  • Suspension
  • Lyophilization
  • Micro-particles                                          

Incorporating early input from our commercial manufacturing sites, we set up initial manufacturing methods at lab scale. We then use sophisticated assays to optimize process parameters to arrive at a process that can be scaled up without problems and that assures consistent product quality following the logic of Quality by Design (QbD). Within our Innovation and Development centers in Graz and Uppsala we have experience with:

  • Testing and definition of critical quality attributes
  • Implementation of a lab-scale manufacturing process, including in-process controls
  • Scale-up from lab scale to clinical trial scale and/or commercial scale, ensuring consistent product quality
  • Implementation of sterility using aseptic filling or terminal sterilization
  • Developmental studies on product stability include:        
    • CH and/or ambient light photo stability
    • Stress stability
  • ICH and/or ambient light photo stability
  • Stress stability
  • Compatibility studies for product contacting parts
  • Compatibility studies with primary container closure system include:
    • Stress stability studies using different primary container closure systems
    • Extractable & leachable studies

Accompanying the development and scale-up of the manufacturing process itself, we also support you in developing and validating the analytical methods needed for raw materials and finished product. In the first instance, analytical methods are implemented in our onsite labs. We can also call on a range of qualified, competent outside partners to develop and implement your analytical methods.

Clinical Trial Supply (Phase I–IV)

Our commercial manufacturing sites are fully compliant with international quality standards (including FDA-GMP, EU-GMP), offering production for global clinical studies in various container closure systems.

After having established a successful manufacturing process for your clinical trial supply, we support you in generating validation and registration batches to obtain market authorization of your product. Complete process validation in accordance with regulatory and cGMP guidelines is essential to the establishment of a reliable high-quality commercial supply. This includes:

  • Process validation with critical parameters
  • Validation of analytical assays
  • Hold time studies
  • Stability studies at required International Committee on Harmonization (ICH) conditions
  • Release testing
  • Chemistry, Manufacturing, and Controls (CMC) documentation in Common Technical Document (CTD) format