Logo of BIofidus AG

Charge heterogeneity

The monitoring of charge heterogeneities of protein-based drugs is an integral part of any quality and product lifecycle management plan. Biologics are susceptible to various enzymatic and chemical post-translational modifications (PTMs) during their production process. These PTMs can significantly change the charge pattern and consequently lead to an alteration of the physical and chemical properties of a protein, such a solubility, stability, and binding affinity. To guarantee the efficacy and safety of biologics or biosimilars, it is inevitably to characterize the product-related impurities arising during the manufacturing process.

As regulatory agencies like FDA or EMA expect charge variants to be thoroughly characterized, a detailed analysis of deamidation, amidation, sialylation or pyroglutamate and lysin variants is of upmost importance during the development and commercialization of biologics.

The insights gained from these studies not only provide necessary knowledge about the product quality and safety, but also guides the development of process control strategies to avoid or reduce undesired charge variants.

In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance (DS), its individual formulation matrix and your distinct analytical question.

Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.

Our capabilities

Standalone and integral bioanalytical services

LC-ESI-TOF mass spectrometry for analysis of
Separation and quantification of charge heterogeneities via

Tell us about your project

We‘ll advice you to define your assay needs

By sending the contact form you agree to our privacy policy.
*By submitting this form, you are consenting to receive emails from: Biofidus AG. You can revoke your consent at any time by using the unsubscribe link, found at the bottom of every email. Please see our privacy policy.

Technologies used

Please reach out to Our expert Dr. Anja Doebbe for all inquiries related to the characterization of charge heterogeneities.

Phone: +49(0)521 89 739 064
Mail: Anja.Doebbe@Biofidus.com

WordPress Cookie Plugin von Real Cookie Banner