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Antibody Characterization

Structural characterization of monoclonal antibodies according to ICH Q6B guidelines

Are you looking for a professional antibody characterization service?

Alphalyse offers a range of analytical services for structural antibody characterization of monoclonal antibodies. We perform our tests according to the ICH Q6B guidelines Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

Our optimized analytical antibody characterization services are suitable for monoclonal antibodies. For instance in early discovery or during process optimization. They can also be used for documentation of clinical batches, and for pharmacokinetic/pharmacodynamic (PK/PD) studies.

You can choose between following services:

Molecular weight of mAb.. (read more)
We determine the exact molecular weight of intact and reduced monoclonal antibodies.

Disulfide analysis of mAb.. (read more)
We determine the number and position of disulfide bridges in monoclonal antibodies.

Peptide mapping of mAb.. (read more)
We confirm the theoretical amino acid sequence of monoclonal antibodies by peptide mapping.

De-novo sequencing of mAb.. (read more)
We determine the exact amino acid sequence of monoclonal antibodies by de-novo sequencing.

Antibody-drug conjugates.. (read more)
We determine the exact distribution of drug-to-antibody ratio (DAR). In addition we find the exact attachment site(s) of the drug molecule.

Send us your project description and we will design a service package meeting your needs.


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