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 progressing to clinical trial stages and upscaling your batch size.
The analysis package could include an assessment of the exact MW, looking at the distribution of PTMs, and con...
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 progressing to clinical trial stages and upscaling your batch size.
The analysis package could include an assessment of the exact MW, looking at the distribution of PTMs, and confirming 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 your specific project. It 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 due to Protein A purification. Therefore, we utilize a native digest protocol with more samples. It increases the sensitivity and ensures that we detect a broader HCP population when performing antibody analysis.
Alphalyse offers a range of services for the structural characterization of mAbs and 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).
