FESTIVAL OF BIOLOGICS 2023
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Chirascan Q100 provides detailed insight into the Higher Order Structure (HOS) characteristics of complex biomolecules.
Reproducible robotics and high performance circular dichroism spectroscopy combine to generate quality data compatible with the most stringent statistical analysis methods. The result: objective, statistically-validated HOS comparisons.
Fully integrated for unattended operation, Chirascan Q100 saves days of operator time, analyzing 48 buffer-sample pairs over 24 hours whereas an experienced operator processes up to 14 samples per day on a manual system.
Increased sensitivity for superior detection
For being able to identify minor spectral differences due to subtle changes in molecular structure, high sensitivity is key—particularly for tertiary structure assessment by near-UV CD and HOS comparisons, e.g., for forced degradation studies.
Calibration with confidence
Conventional chemical calibration methods require considerable skill in preparation. Standards, such as camphor-10-sulfonic acid (CSA), are unstable, photolabile, and hygroscopic. In addition, single-wavelength calibration (290.5 nm) assumes the same linear response at all wavelengths.
The optics-based, multiwavelength calibration method used for Chirascan V100 and Chirascan Q100 systems overcomes these challenges. The correct calibration is applied to every wavelength to yield accurate CD values.
Chirascan systems are supplied with the features and accessories required for acquisition of high quality data from ‘day one’.
Optimized for Chirascan Q100
The software includes comparison methods and statistics associated with several statistical methods. However, we recommend calculating z-scores to quantify the similarity between a single spectrum and the reference dataset for each sample using ‘weighted spectral difference’ Dinh et al.
For more information about quality range tests consult guidance documents from the relevant regulatory agencies. For example: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations – Guidance for Industry, CDER, FDA
*Analyses with three or four replicates can be sufficient for proof of principle studies, but statistical analysis with less than three replicates is not mathematically possible
Note: t-tests are not recommended for HOS comparisons and are absent from the statistical approaches recommended by regulatory agencies at this time.