Antibody analysis

Characterization of mAb

Do you develop or manufacture a monoclonal antibody (mAb) – or maybe an antibody-based biosimilar product?

Then you probably already know that an extensive antibody characterization is needed before you can progress to clinical trial stages and upscale your batch size.

The analysis package could include confirmation of the antibody sequence...

Do you develop or manufacture a monoclonal antibody (mAb) – or maybe an antibody-based biosimilar product?

Then you probably already know that an extensive antibody characterization is needed before you can progress to clinical trial stages and upscale your batch size.

The analysis package could include confirmation of the antibody sequence, assessment of the exact MW and a look at the distribution of PTMs. As well as identification and quantification of residual host cell proteins (HCPs).

Customized projects

We customize every project to the specific product. This means that you are not simply buying a single antibody analysis. Instead, you are starting a collaboration where we…

  • Explain all analysis steps in detail.
  • Facilitate meetings where your team are updated on the status and presented results.
  • And provide you with the newest knowledge and instrumentation for HCP analysis.

Many mAbs have a low number of HCPs. This is due to the use of Protein A purification, and therefore we utilize a native digest protocol with higher amount of sample. This increases sensitivity and also ensures that we detect a broader HCP population.

Alphalyse offers a range of services for structural characterization of mAbs – and also for antibody biosimilars. Thus, you can use them to optimize the process development of your antibody product. Rest assured that we always perform our tests according to the ICH Q6B guidelines. (Test Procedures and Acceptance Criteria for Biotechnological/Biological Products).

Choose and combine your preferred antibody analysis package from the services below:

MoreLess details

Start the collaboration

We offer customized solutions, contact us to discuss your project.

Ask a question or get a quote

Send us a description of your project and we shall be happy to present you with a solution.





Attach a file (Optional)
Select file

Set up a phone meeting

We encourage you to call us or schedule a meeting to discuss your project in detail.

Set up meeting

Direct phone numbers

More info

Monoclonal antibodies are now the biggest group of biological drug therapies. Therefore, many pharmaceutical companies rely on mAb characterization services that determine both physiochemical and structural properties, along with PTMs, purity (and impurities) and stability.

Alphalyse offers antibody analysis of a quality suitable for IND/BLA approval, demonstrated through hundreds of cases where customers have used the results for early development, pre-clinical studies, commercial clinical trials and for batch comparability and release tests.

The tests can be conducted for characterization of mAbs and derivatives such as biosimilars, antibody-based immunotherapies and other antibody formats like minibodies, ds-scFv, scFab, sdAb and F-Cab – even various isotypes and allotypes. The light and heavy chain can be analyzed separately (intact and reduced), an overview of the variable region (VJ and VJD regions) can be achieved, even if the B-cell hybridoma is not available. Popular analyses also include monoclonal antibody peptide mapping and mAb terminal amino acid sequencing.

Who is this for?

We primarily help customers within the pharmaceutical industry, and biotechs working on drug development, e.g.

Project managers

Working with process development and characterization projects.

Analytical experts

Protein scientists that work with elisa, masss spectrometry, or CMC.

Sign up for the newsletter
Subscribe to get 3 tips that will instantly improve your protein analysis results

Receive monthly emails with news, tips, case stories
and offers for protein analysis
Private, secure, spam-free
© Copyright Alphalyse 2002 - 2020. All rights reserved.