Analytical Development

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Analytical Development Services

We can support the development of your process from start to finish with a comprehensive suite of in-house platform methods, high throughput methods for screening phases, e.g. clone selection, methods tailored to your protein and phase-appropriate for your process.

We offer:

  • Large number of platform methods
  • Support on early phases of Cell Line Development
  • Support for development of your Upstream and Downstream Process and scale up
  • Analytical methods development and validation
  • Protein characterization (integrity, structure, identity, purity)
  • Cell-based Potency assays 
  • Analysis of process- and product-related impurities 
  • Comparability exercise according to ICH Q5E guidelines
  • Preliminary Stability study according to ICH Q5C for Drug Substance to give you minimal quality prerequisites for IMPs submission
  • Forced degradation study according to ICH Q1A, Q1B and Q2B guidelines
  • The whole workflow to support your process is based on the Quality by Design approach according to ICH Q14 guidelines for more robustness to your data.

Bioassays Portfolio

A specialized team will support you from cell bank preparation for analytical purposes (WCB), identification of the most appropriate method based on your product and Mechanism of action, and then method development and optimization up to validation.

The DOE is applied from development to validation to make your results more robust and through statistical analysis we support stability data and batch to batch comparability.

You will be able to have platforms to verify the mechanism of action of your product including (and not limited to):

  • Complement dependent cytotoxicity (CDC) assay 
  • Antibody dependent cytotoxicity (ADCC) assay
  • Cell-based Competition assays by SPR technology