Fraunhofer Institute for Cell Therapy and Immunology, Branch Bioanalytics and Bioprocesses IZI-BB
Fraunhofer Institute for Cell Therapy and Immunology, Branch Bioanalytics and Bioprocesses IZI-BB

Tailored Solutions for Drug Development

Optimize Your Life Cycle Management

We develop an individual process for you in accordance to your needs
and the 3R protocol – from the idea to the finished drug.

Our Services:

  • Cell-based toxicity studies
  • Protein engineering and modification
  • Cell culture facility and pathogenicity testing (up to S2)
  • Drug characterization & metabolization
  • Analytical and bioanalytical facilities (e.g. CLSM, HRMS, NGS, FACS)
 

Drug Discovery

Efficient syntheses of various biopharmaceuticals such as antibodies via protein engineering in parallel and adjustment by payload coupling.

 

Drug Metabolisation

Combination of metabolite screening, synthesis and analytical characterisation. Metabolisation by fungal peroxygenases (UPOs) in a fast high-throughput screening or physiological and precise in vitro liver-model enabling CYP profiling.

 

© Potsdam Science Park/ sevens+maltry

Drug Safety and Efficacy

Development of an individual process in accordance to the 3R protocol to reduce and replace animal models.

We Customize and Shorten Your Drug Discovery Process

We perform targeted and efficient syntheses of various biopharmaceuticals such as antibodies by implementation of protein engineering in parallel including mutation analyses and subsequent drug characterization by high-throughput screenings. The rapid processing is possible because we make use of the synthesis apparatus of cell lysates, meaning that we perform cell-free protein synthesis. If additional modification is required, we adjust your biopharmaceuticals to couple payloads, e.g. for ADC generation. We then scale up the production of your identified and optimised drug in a cell-based expression system if needed.

We Offer a Complete Platform for Drug Metabolization

We Combine Metabolite Screening, Synthesis and Analysis

Drug metabolisation is a major bottleneck in pharmaceutical development for ADME and toxicity studies. To achieve this, we combine metabolite screening, synthesis and analytical characterisation. You can choose to analyse the metabolism of your pharmaceuticals either by fungal peroxygenases (UPOs) in a fast high-throughput screening or use our physiological and precise in vitro liver-model enabling CYP profiling. At last we offer an overall analytical process for the quantification and structural elucidation of metabolites.

We Screen Your Drugs for Safety and Efficacy

During drug development we can support your safety and efficacy testing. We offer three different types of in vitro analyses with increasing degrees of complexity, which can also be implemented in succession. Firstly, fast and efficient cell assays using 2D cell cultures growing in monolayers form the basis for the initial selection of drugs for toxicity and efficacy screening. Secondly, we investigate the impact of your drug using 3D cell models which offer a more complex architecture and the associated higher tissue-specific functionality e.g. liver spheroids and tumor organoids. Thirdly, we can use microphysiological systems such as organ-on-chip (OoC) technologies to precisely control the environment of complex 3D cell models, e.g. considering pharmacokinetics and enable long term cultivation. By combining this with real-time measurements of cell metabolism, we can detect the influence of concentration changes and investigate regeneration upon repeated dosing. We can develope an individual process for you in accordance to the 3R protocol to reduce and replace animal models.