App Banners Industryapplications V3 (1)

Use cases in biopharma

Maintain project momentum

From QTPP to regulatory submission

The slightest change in Higher Order Structure (HOS) can significantly impact the efficacy and immunogenicity of a biotherapeutic. HOS analysis is therefore well-established as one of many Critical Quality Attributes (CQAs) used to characterize the structure, purity, function, and stability of a potential biotherapeutic candidate.

Chirascan Q100 Alpha High Quality

Fulfill demands for more stringent HOS analysis

Assessment of HOS based on CD data has for many years been based on simple graphical comparisons. Now, the Chirascan Q100 system for CD analysis allows for a quantitative approach to rigorous statistical analysis as recommended by the Office of Biostatistics and Office of Biotechnology Products (CDER/FDA).

Capable of detecting minor differences in secondary and tertiary structure, and offering high reproducibility thanks to defined experimental procedures using liquid handling, the system generates high-quality raw data to enable quantification of similarities and differences and confirm their statistical significance. Previously subjective HOS comparisons now contribute to objective, informed decision making.

Biotherapeutic Characterisation

HOS Comparisons

Make Informed Decisions

Advance your biotherapeutics development with Chirascan systems

Characterize higher order structure
  • Confirm structural integrity of your biotherapeutics
  • Determine and compare HOS characteristics of lead candidates
  • Make use of both far- and near-UV CD and orthogonal intrinsic fluorescence for complete HOS assessment
Support conclusions and add to the bigger picture
  • Quantify and evaluate the significance of minor changes under native and stressed conditions
  • Gain insight into mechanisms and interactions, detect differences between wild type and mutant
  • Screen formulations and assess impact of different conditions such as pH, ionic strength, and presence of excipients
Run effective comparability programs
  • Confirm similarity between biosimilar and innovator
  • Evaluate innovator variability
  • Monitor change throughout development and scale-up
  • Strengthen totality of evidence for regulatory submissions
Satisfy regulatory demands
  • Define acceptable quality range for HOS variability within a process control strategy
  • Obtain highest-quality data with state-of-the-art instrumentation
  • Apply the most rigorous statistical methods in data analysis
  • Contribute to characterization profiles to fulfil ICH Q6B/Q8
Embrace best practice
  • Eliminate user bias and increase reproducibility with automated liquid handling
  • Strengthen your Quality by Design (QbD) approach
  • Objectively evaluate structural changes with support of statistically-validated data
  • Complete your Quality Target Product Profile (QTPP)

App Notes

Check out our Circular Dichroism application notes!