Antibody Drug Conjugate

Accurate and rapid Antibody Drug Conjugates (ADCs) characterization

Resolve the complexity of your ADCs

Monoclonal antibodies (mAbs) are a growing class of therapeutic proteins that can be used to target proteins with great selectivity. With this high selective power, specific cells mechanisms can be modified such as tumor growth inhibition in oncology indications.
The added complexity of combining a cleavable linker and a cytotoxic drug to an already complex monoclonal antibody product requires improved analytical methods. It is not only necessary to control the antibody drug conjugate expected protein micro-heterogeneities but also the drug loading, the drug-to-antibody ratio (DAR), the amount of free antibody and drug, and the linker chemistry.

ADC

The dynamic range of Bruker ultrahigh resolution QTOF such as maXis II is a key element for the successful characterization of ADCs.

A key ADC assay is the determination of the drug distribution profile. This often needs to be performed in native conditions and in the presence of heterogeneity such as glycosylation and formulation impurities. The ability to measure the ADC signal with accurate relative intensities in the presence of these interferences makes the maXis II with high mass option the preferred instrument for drug distribution measurements.

ADU

Another essential attribute is the drug to antibody ratio (DAR). It can be derived from the drug distribution assay but can also be measured at the reduced or subunit level. This yields additional insights about linker hydrolysis or drug degradation. The maXis II can carry out these measurements with isotopic resolution enabling sensitive and confident detection of such degradation products. This same assay is also helpful in the research phase in order to compare the developability of various scaffolds or linker chemistries.

Finally it is essential to understand the degradation pathways of the antibody drug conjugate in vivo or in plasma incubations. The sensitivity of the maXis II for high molecular weight species makes it possible for researcher to undertake these studies at biologically relevant concentration.

When developing ADCs, new analytical challenges constantly need to be addressed. Keep your research and development fast and agile with the
maXis II ultrahigh resolution QTOFs

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