Vaccine analysis

Analysis of the recombinant protein content of your vaccine

Alphalyse offers several services for analysis and characterization of vaccine products. First of all, we utilize mass spectrometry for accurate determination of sequence, molecular weight, purity etc. It is both useful in your process development and final product analysis.

We perform all our tests according to the ICH Q6B guidelines – Test Procedures ...

Alphalyse offers several services for analysis and characterization of vaccine products. First of all, we utilize mass spectrometry for accurate determination of sequence, molecular weight, purity etc. It is both useful in your process development and final product analysis.

We perform all our tests according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

You can choose and combine your preferred analysis package from the below services.

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Vaccines are often highly complex and thus pose a challenge for vaccine characterization strategies. Both identity, purity and potency, as well as stability testing must be looked upon to meet regulatory standards and clinical administration.

Thus, analytical support services are crucial for vaccine stabilization, batch to batch comparison and assessment of immunogenicity, but viral particles must first be attenuated or killed to permit thorough characterization. However, some vaccine components are virus-like particles that are non-infectious and instead closely resemble native viruses.

The complexity and the suitable analyses depend on the type of antigenic component(s) and other excipients like adjuvants in the vaccine formulation. Biophysical techniques are needed to assess the physiochemical properties and antigen structure.

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.

Experts

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