Analysis for the determination of a biologic drug’s higher order structure
Mnova BioHOS is designed for the NMR analysis of biotherapeutics, like monoclonal antibodies. 2D NMR spectra of reference samples are compared with that of each test sample using a fingerprinting, or spectral similarity determination.
Licenses of Mnova NMR and Chemometrics are required to use Mnova BioHOS
Designed in collaboration with Bruker BioSpin, Mnova BioHOS capabilities will support your analytical needs for the Quality Assessment of Biologic drugs using 2D NMR spectral data.
What’s new in Mnova BioHOS 2.0?
The latest version 2.0 was released with Mnova 14.2 and these are the main highlights:
- 1D PROFILE analysis
This uses 1D NMR spectra. Small spectral changes are detected and a statistical analysis performed on evaluations
- PCA models and distance calculation
Sample spectra can be used to generate a “PCA model”, and tools are made available for validation. New samples can be tested against the model, and Mahalanobis distances (Dm) calculated
- Matrix evaluations of all spectra
All samples are automatically compared with each other and a table of results with colour coding makes it easy to compare inter- and intra class samples
1D PROFILE analysis
Mnova BioHOS: 45-day free trial version
Download Mnova for a suitable Operating System
Open Mnova and go to ‘Help/Get-Install Licenses’. Select ‘Evaluate’.
Fill in the form to receive your trial license via e-mail.
Help & Resources
Mnova BioHOS – NIST mAb data
Reference: Robert G. Brinson at al. (2019) Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics, mAbs, 11:1, 94-105
Data relating to the NISTaMb Interlaboratory study and useful reference material can be found here
- Pairwise intensity comparisons of points with the same coordinates in the reference – and test spectra
- A regression line is computed for the scatter plot of points. Manual and automatic noise cancellation
- Adjust threshold for residuals
- Selected peaks in the reference spectrum are matched with peaks in the test data and the Combined Chemical Shift Difference (average and per peak pair) is calculated
- Average CCSD for each test spectrum, to rank them by similarity with the reference
- Plot CCSD values and amplitude ratio per pair of peaks and inspect relevant spectral regions with just one click
- Dedicated features for data management including: adjusting preparation parameters, binning to reduce data size, conducting integrity checks, filtering, normalizing and scaling
- PCA results available in interactive plots always connected to the spectra
- Explained Variance, Influence, Scores and PCA loadings plot templates available
This uses 1D NMR spectra. Small spectral changes are detected and a statistical analysis performed on evaluations.
- Typically uses 1D 1H spectra
- Small differences are quantified
- Statistically treat spectra for many spectra
Academic, Government & Industrial
- NMR Quality Assessment of biologic drugs
- Similarity assessment of generic biologic drugs
- Suitable for Pharmaceutical companies, CROs and academic organizations