NMR & EPR Pharma Solutions

Biologics Higher Order Structure

Evaluating the Higher Order Structure (HOS) of an intact protein/antibody in physiologically relevant buffer. Small, but relevant changes in the HOS are detected at atomic resolution.

Destaques

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.   

 

Características

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.

Aplicações

Software

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

Testemunhos

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.
 

Apoio

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