Biologics HOS

True HOS

Evaluates all aspects (primary, secondary, tertiary, and quaternary) of HOS.

Atomic Resolution

Small but relevant changes in the HOS can be detected using 1D PROFILE, ECHOS, CCSD, and/or PCA. Each of these methods highlight spectral differences, which can be assigned to a region in the protein.

Physiological Conditions

NMR acquisition methods have recently been enhanced enabling the study of intact molecules (150 kDa) at natural abundance in physiologically relevant conditions.

The latest generation of NMR instrumentation, combined with newly developed NMR acquisition methods, means that intact molecules, including antibodies (150 kDa), can be characterized at natural abundance, in formulation buffer or other physiologically relevant conditions. Differences between batches are detected by comparing the spectrum of a batch with a reference, thus allowing rapid pass/fail decisions to be made.

Features

Easy acquisition: The latest generation of NMR instrumentation affords high spectral resolution and high sensitivity. When combined with newly developed NMR acquisition methods, this enables the study of intact molecules, including antibodies (150 kDa) at natural abundance in formulation buffer or other physiologically relevant conditions.

Easy analysis: Easy-to-use NMR analysis software also makes this solution accessible to non-NMR experts.

Similarity assessment: Published & accepted methods are available
o   PROFILE 1D
o   PCA – unsupervised chemometrics
o   Multivariate statistic model building and distance calculations
o   ECHOS – simple representation of spectral differences
o   CCSD – represents shifts in peak positions.
Matrix analysis for the comparison of batches
Integrated solution: Data and results are linked, enabling the reason(s) for any observed spectral differences to be determinated.

Changes in peak positions and amplitudes are related to structural changes. Combined Chemical Shift Deviation (CCSD) tracks individual peak changes, summarizes them into one quality factor, and points to individual differences.

PCA distance calculations can not only be used to quantify class differences, but also distance between a class and a spectrum. The distances can be shown as numbers and in an Influence plot.

For scientists, using fast 1D NMR experiments to evaluate the HOS, 1D PROFILE searches for small differences between spectra. Batch-to-batch comparisons by matrix analysis, comparing all spectra, show similarity statistics, visualized by Box plots. Individual visual comparison of results by offering an overlay of spectra, broadened, and fingerprint spectrum.

PCA analysis: the spectroscopic reason for statistical differences between classes can be displayed together with the spectra.

Principal component analysis (PCA), a multivariate statistics method, highlights variances in the dataset. This unsupervised method enables the comparison of batches using 1D or 2D NMR spectra. The difference between batches can be expressed as a single number. When combined with data on the spectroscopic reason for the difference, this approach enables profound structural insights to be revealed

ECHOS (Easy Comparability of Higher Order Structure) compares the spectra pointwise. A linear regression analysis between two spectra evaluate the similarity. Individual residuals, displayed using a heat color map on top of the spectra, highlight differences between the spectra.

Applications

Software

Mnova BioHOS software features

Easy-to-use NMR analysis software makes this solution accessible to non-NMR experts
Similarity assessment. Published & accepted methods are available
- PROFILE 1D
- PCA – unsupervised chemometrics
- Multivariate statistic model building and distance calculations
- ECHOS – simple representation of spectral differences
- CCSD – represents shifts in peak positions
Matrix analysis for the comparison of batches
Integrated solution: data and results are linked, giving insight on the potential reason(s) for observed spectral differences.

Webinars

Testimonials

NMR lab visit at Health Canada

2D NMR Methods to Quantify Heparin Composition (Pharmaceutical Analysis

Quality assessment of biologics and biosimilars at atomic level

Dr. Fabio Baroni, Merck KGaA, Rome, Italy

The need for high-resolution techniques for the characterization of Higher Order Structure of biologics is regarded as being extremely urgent, especially in the case of application to biosimilar development.
NMR, besides assuring an atomic-level fingerprint of the molecule’s structure, grants a resolution and sensitivity to structural changes incomparable with any other spectroscopic technique. Bruker, has led multiple developments in NMR during the last decade in terms of improved instrumentation, clear workflows and enhanced data analysis and finally, has made the employment of the technique in biosimilar R&D.

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