Biopharma

Higher Order Structure

Gain Insights to Protein Structure

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Quality Assessment of Biologics and Biosimilars at Atomic Level

Unlike small-molecule drugs, biologics are produced in living systems, processing not only primary, but secondary, tertiary and possibly quaternary structures. Determination of a biologic drug's higher order structure (HOS) is critical to ensure efficacy, stability, and safety.

NMR is perfectly suited to evaluate protein structures and assess whether critical changes have occurred in a biotherapeutic drug during development and manufacturing. Due to its intrinsically high information content, NMR is proving to be a uniquely valuable tool for the evaluation of HOS, thus reducing the number of techniques needed to characterize biotherapeutic drugs. Recent advances in data acquisition and analysis mean that it is now possible to study intact materials (including monoclonal antibodies) at natural abundance, under conditions that are physiologically relevant. The new MbioHOS software offers a tool box of 1D and 2D method to evaluate the higher order structure of biotherapeutic drugs. Additionally, the assessment of similarity between a biosimilar drug and its reference material is now fast and easy, allowing rapid pass / fail evaluations to be made.

Click here to view exclusive biologics and biosimilars content.

Using FT-IR as an Orthogonal Technique in HOS

FT-IR strenghtens the portfolio of orthogonal techniques for HOS analysis by giving insight into the secondary structure of proteins. The analysis is performed rapidly (~1 min/sample) and is characterized by a high tolerance against varying sample properties such as protein concentration, buffer components and excipients. These attributes make the method an optimal tool for monitoring the conformation of biopharmaceutical proteins during the development phase and for routine quality control.

This example application shows the IR spectra of an antibody at different temperatures (25-95° C). As indicated by the unchanged amide I band shape the protein maintains its native-sheet structure up to ~60° C. Further heating causes a decrease in intensity, which indicates the unfolding of intramolecular-β-sheets.

Webinaires

Webinars

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September 8, 2020

Comparability studies of Pharmaceutical Proteins by 2D NMR fingerprint

An important aspect in analytical assessment of pharmaceutical proteins is the comprehensive characterization of their higher order structure (HOS).
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August 18, 2020

NMR Spectroscopy for Robust Assessment of the Higher Order Structure of Biologics

Biopharmaceuticals are the fastest growing segment of the pharmaceutical industry. Similar to the concept of generic drugs
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June 09th 2020

Introduction to antibodies and their analytical characterisation

During this webinar Dr. Maurizio Muroni from Astra Zeneca, Cambridge, UK, will give us an introduction on what antibodies are, their structure and an overview of some of the analytical techniques used for their structural characterization.
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Sep 13, 2019

Advancing Biotherapeutics Characterization with Ultrahigh-Resolution Mass Spectrometry and a Toolbox of Separation Methods

This seminar highlights the needs and versatility of ultrahigh-resolution mass spectrometers for heightened mAb characterization in Pfizer’s MSBC lab, as well as addresses the importance of different separation techniques coupled to MS.
NMR offers superior resolution, sensitivity, and characterization of multiple structural aspects with a single experiment.
May 14, 2019

Evaluation of Higher Order Structure of Biologics at Atomic Resolution using NMR

The need of high-resolution techniques is overall regarded as urgent for Higher Order Structure (HOS: secondary, tertiary and quaternary structure)
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September 27, 2018

Quality Assessment of Biologics: Higher Order Structure (HOS) Analysis using NMR

The webinar will describe how 2D NMR can offer protein biochemists unprecedented analytical precision.

Support

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