Charge Variants Analysis of Antibody Drug Conjugates

Charge heterogeneity is an important characteristic of ADCs, which not only reflects the homogeneity of the drug product, but also relates to the quality and efficacy of the ADCs. Creative Proteomics has extensive expertise in charge heterogeneity analysis of antibody drug conjugates. With advanced instrumentation and robust methodologies, we can accurately identify and quantify the various charge variants present in ADCs to help clients assess the safety, efficacy and stability of ADCs. Our accurate assay data and comprehensive analytical reports support pharmaceutical manufacturers in making informed decisions during the development, formulation and quality control stages of ADCs.

Challenges of Charge Variants Analysis in ADCs

Charge variant analysis is an important aspect of characterizing the quality attributes of antibody drug conjugates. However, charge variant analysis of ADCs can be challenging for a number of reasons, including the following:

• Steps such as drug coupling, purification processes, and various post-translational modifications (including enzymatic or chemical degradation) increase the complexity of the charge heterogeneity of ADCs, resulting in ADCs molecules possessing a wide range of variants with different charge states.
• The complex charge variant profile of an ADC may not readily correlate to certain charge-altering chemical degradation pathways, including Asn deamidation, glycation, and Asp isomerization (when forming succinimide intermediate).
• Due to the possibility of multi-site attachment of small molecule drugs and potential non-specific interactions with the column stationary phase, methods applied to parent antibodies may not be applicable to ADCs or may give significantly different information.

Therefore, there is a need to develop robust and suitable analytical methods to accurately and reliably characterize the complex charge variants and charge distributions in these therapeutic molecules.

ADCs Charge Variants Characterization Methods at Creative Proteomics

The scientists at Creative Proteomics provide expertise and cutting-edge analytical techniques for the analysis of antibody drug conjugates. We are unique in that we understand that each ADC is unique, and that charge variants can arise from a variety of sources such as drug degradation, conjugation chemistry, or modification of linkers and coupling sites. Our characterization experts will work closely with our customers to understand their product properties and develop a compliant assay for them.

Our charge variant analysis uses advanced detection techniques to accurately detect and quantify charge variance in ADCs, ensuring a comprehensive understanding of ADC characteristics.

Creative Proteomics leverages our expertise and advanced technology to provide customized analysis services for the unique characteristics of different ADCs. Contact us to learn more about our service and we will be happy to serve you.