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Clinical Trial Supply


Sterile pharmaceuticals for clinical trials

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

 

Selection of containers for clinical trials

    • Vials: 10 to 100 mL
    • Bottles: 50 to 1000 mL
    • Ampoules:1 to 20 mL
    • Pre-filled syringes: 1 to 50 mL
    • Bags (PVC free): 50 to 1000 mL

  

Aseptic compounding

    • Single- and multi-chamber bags, syringes, pumps
    • Parenteral nutritrion, cytostatics, antibiotics and others

 

Dedicated plants for clinical trial supply


 

Global clinical trials trust in our manufacturing expertise

 

As part of our one-stop-shop philosophy, developing and manufacturing sterile medications for clinical studies has become a central part of our third-party services. Fresenius Kabi Product Partnering supports global clinical trials with manufacturing and aseptic compounding of GMP batches and blinding of study medication. The main centres for these activities are our dedicated pilot plant in Graz, Austria and our plant in Neufahrn, Germany. If a specific requirement cannot be met by either of these two plants, we can make use of our global network of more than 25 commercial plants. As a result, we are a reliable partner during all of the clinical phases I-IV.

 

Over the last decade, the pilot plant in Graz, Austria has become a central manufacturing site for global clinical studies carried out by our customers, thanks to regulatory approval by major authorities (e.g. FDA, EMEA). The pilot plant with its affiliated analytical laboratory offers a higher degree of flexibility for manufacturing GMP batches than our highly automated commercial plants. To save costs and time for the clinical study, our pilot plant is equipped to fill a single bulk solution into multiple container closure systems (e.g. glass vials and PVC-free bags of different volumes) for testing various sizes and types of container in the clinic. Besides manufacturing complex aqueous solutions, a set of homogenizers enable us to manufacture emulsions, liposomal formulations and suspensions from 5 L up to 1000 L. The pilot plant’s freely programmable autoclave includes the option for rotating cycles, meeting the special sterilization needs for sophisticated formulations. For high-potent APIs, a special pharma lab was commissioned in 2008 in order to develop and manufacture pharmaceuticals with APIs up to an OEL level of 4.

 

Fresenius Kabi’s centre of excellence in aseptic compounding in Neufahrn, Germany, specializes in manufacturing highly individualized sterile solutions in small scale batches (1 to 1000 units). Predominantly manual processes ensure the highest possible flexibility e.g. in using different container closure systems or in preparing personalized investigational medicinal products (IMPs). In addition to aseptic compounding, the Neufahrn plant specializes in blinding, labeling and secondary packaging of different kinds of small to medium size batches of different IMPs (e.g. bags, vials, bottles).

 

A team of highly trained engineers and scientists offer their services to prepare your sterile pharmaceutical drug and also support the scale-up phase. A toolkit of developmental assays helps us to optimize process parameters for a smooth scale-up and consistent product quality following the Quality by Design guideline.

 

Once the medication is approved, a dedicated project team coordinates the product transfer to one of our commercial plants, taking advantage of the experience and knowledge of the development and manufacturing process gained during the clinical phase.