Biologics Higher Order Structure
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 provides high spectral resolution and sensitivity. Combined with newly developed acquisition methods, this enables the study of intact antibodies (MW 150 kDa) at natural abundance, in formulation buffer, or under 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
- 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, enabling the reason(s) for any observed spectral differences to be determined.
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, enabling the reason(s) for any observed spectral differences to be determined.
Testimonials
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.
LabScape
Service & Life Cycle Support for Magnetic Resonance and Preclinical Imaging
Bruker’s commitment to provide customers with unparalleled help throughout the buying cycle, from initial inquiry to evaluation, installation, and the lifetime of the instrument is now characterized by the LabScape service concept.
LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory
