Exploring chemical space for new substances to stabilize a therapeutic monoclonal antibody

November 5, 2019

Tosstorf, A., Menzen, T., Winter, G.

Journal of Pharmaceutical Sciences 2020, vol: 109(1) doi: 10.1016/j.xphs.2019.10.057

Abstract

The physical stability of therapeutic proteins is a major concern in the development of liquid protein formulations. The number of degrees of freedom to control a given protein's stability is limited to pH, ionic strength, and type and concentration of excipient. There are only very few, mostly similar excipients currently in use, restricted to the list of substances generally recognized as safe for human use by the U.S. Food and Drug Administration. Opposed to this limited number of available excipients, there is the vast chemical space, which is hypothesized to consist of 1060 compounds. Its potential to stabilize proteins has never been explored systematically in the context of the formulation of therapeutic proteins. Here we present a screening strategy to discover new excipients to further improve an already stable formulation of a therapeutic antibody. The data are used to build a predictive model that evaluates the stabilizing potential of small molecules. We argue that before worrying about the hurdles of toxicity and approval of novel excipient candidates, it is mandatory to assess the actual potential hidden in the chemical space.

View Publication

Topics: Prometheus, nanoDSF, Biologics, Publications

Previous Article
Understanding the process-induced formation of minorconformational variants of Erwinia chrysanthemi L-asparaginase
Understanding the process-induced formation of minorconformational variants of Erwinia chrysanthemi L-asparaginase

Up next
nanoDSF as screening tool for enzyme libraries and biotechnology development
nanoDSF as screening tool for enzyme libraries and biotechnology development

Ready to tackle your challenging stability characterizations?

Discover tools
×

Sign up to receive
the latest NanoTemper news, product updates, event announcements and more

First Name
Last Name
Company Name
Country
State
Province
State
Region
State
Canton
Agree to Subscribe & Privacy Policy*
*I have fully read, understood and agree to the Privacy Policy. I accept the storing and processing of my personal data by NanoTemper as described in the Privacy Policy.

By completing this form, you provide us consent to contact you with educational content, news and information about our products, services and events. You may unsubscribe at any time.
Thank you!
Error - something went wrong!