Absolute quantification of mAbs and ADCs:
forget amino acid analysis and shift to the new gold standard

Absolute quantification of proteins (i.e. quantification without the need for a reference standard) is a key analysis for the qualification of reference standards or to determine the extinction coefficient of a protein. It is usually performed using amino acid analysis, but this technique shows limited accuracy and repeatability.

Quality Assistance has developed an innovative method based on the quantification of sulphur by isotope dilution ICP/MS. Unprecedented precision and accuracy can be obtained, which provides a reliable quantification of proteins and determination of extinction coefficients.

During this webinar, we outlined the steps we took to successfully develop this test solution, the results of the validation study, and the application of the method to monoclonal antibodies and antibody-drug conjugates.

This method was recently nominated for the essenscia Innovation Award and included in the list of 5 high-potential innovations.

KEY LEARNING OBJECTIVES

Access this 45-minute-webinar to learn how ICP/MS can be used for the absolute quantification of proteins, with precision and accuracy that cannot be reached with amino acid analysis. After a description of the development and validation of the method, its application to monoclonal antibodies and antibody-drug conjugates were presented.

WHO WILL BENEFIT ?

• Analysts

• Scientists

• Project leaders

• Managers

• Directors

in the biopharmaceutical industry, involved in:

• development and characterisation of biotherapeutics

• qualification of reference standards

• comparability and biosimilarity studies

EXPERTISE & CAPACITY

We provide a complete dedicated service:

• A management team who can help you define the technical solution that best suits your needs

• In accordance with GxP quality standards, as required by the study

• Specialised, highly skilled scientists at the bench