Higher Order Structure (HOS) Analysis: a Kaleidoscopic Analytical Method Approach to Understanding Structure-Function-Relationships in Biologics

Heilbronn/Dortmund, March 2021: Due to its large size a biopharmaceutical generally exhibits complex three-dimensional higher-order structures (HOS) which are important factors in the protein”s biological function and activity – and thus essential for the therapeutic”s in-vivo efficiency and safety. At the same time they might influence its stability and toxicity. As a consequence, encompassing information on a molecule”s HOS is invaluable for a successful development. The process of gathering the required information calls for the application of different analytical techniques. Protagen Protein Services (PPS) offers a precisely fitting portfolio of analytical methods to asses structure-function-relationships.

Valuable knowledge through all phases of the development
Secondary and tertiary structural elements are mainly generated by a hydrogen bonding network. Covalent disulfide linkages are key elements building up the complex three-dimensional structure of a biologic. This structure may be affected by the production, purification conditions and/or the handling as well as by the protein”s storage. It is crucial to dispose of orthogonal and reliable methods that provide detailed insights into a molecules”s higher order structure within different phases of its development. Only a well-rounded bundle of state-of-the-art analytical methods can give the highest possible degree of evidence of a protein”s complex HOS. The information given by applying these technologies provides valuable knowledge from early research and development through to phase I/II studies (comparability).

HDX studies via mass spectrometry
Most analytical methods for HOS are spectroscopic approaches, such as FT-IR, CD, fluorescence, or Raman, others are microscopic, such as electron microscopy (EM). Protagen Protein Services offers the according portfolio of methods for analyzing different attributes of HOS in order to come as close as possible to the molecule”s nature by getting maximal insight into the biotherapeutic”s structure and stability. Before all, hydrogen-deuterium exchange (HDX) studies via mass spectrometry have become a critical tool for measuring changes in protein conformations and for studying the protein”s higher order structure. PPS has long understood the impact of HDX in helping customers develop a well characterized biopharmaceutical product and provides the according solutions and expertise.

The most conclusive technologies, bundled in one hand
From Circular Dichroism (CD) for the measurement of polarized light near UV range, Fourier Transformed Infrared Spectroscopy (FT-IR) for the fast analysis of secondary structure features, Fluorescence Scans, Disulfide MS and Ellman tests targeting the determination of free thiols to of testing methods like Differential Scanning Calorimetry (DSC), Dynamic Light Scattering (DLS), Analytical Ultracentrifugation, Chromatography, Protagen Protein Services is perfectly positioned with the most up-to-date technologies and teams of highly skilled experts. If you want to learn more about the broad analytical spectrum that is offered by PPS see protagenproteinservices.com.

Protagen Protein Services (PPS) is a world leading CRO and a recognized expert in mass spectrometry methods for analytical services in protein science and gene therapy. Over 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry. PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity. For developing new biological entities (NBEs) PPS supports customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.

Contact
Protagen Protein Services GmbH
Tobias Timtner
Inselwiesenstraße 10
74076 Heilbronn
Phone: 07131/74504-0
Fax: 07131/74504-299
E-Mail: marketing@protagenproteinservices.com
Url: https://www.protagenproteinservices.com/

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