Antibody analysis
Characterization of mAb
Do you develop or manufacture monoclonal antibodies (mAb) – or maybe an antibody-based biosimilar product? Then you know that extensive antibody analysis is needed before you can progress to clinical trial stages and upscale your batch size.
The analysis package could include assessment of the exact MW, a look at the distribution of PTMs, an...
Do you develop or manufacture monoclonal antibodies (mAb) – or maybe an antibody-based biosimilar product? Then you know that extensive antibody analysis is needed before you can progress to clinical trial stages and upscale your batch size.
The analysis package could include assessment of the exact MW, a look at the distribution of PTMs, and confirmation of the antibody sequence. As well as identification and quantification of residual host cell proteins (HCPs), if needed.
Customized mAb analysis projects
We customize every project to fit to your specific project. This means that you are not simply buying a standardized antibody analysis. Instead, you are starting a collaboration where we…
- Explain all analysis steps in detail.
- Facilitate meetings where your team is updated on the project status.
- And provide you with the newest knowledge and instrumentation for antibody analysis including 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 a higher amount of sample. This increases the sensitivity and also ensures that we detect a broader HCP population when we perform antibody analysis.
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).
