Vaccine analysis

Analysis of the recombinant protein content of your vaccine

Do you develop or manufacture any type of vaccine? And are you looking for the most extensive vaccine characterization of batches, process steps and residual impurities? To ensure patient safety, heighten drug stability, not risk any developmental delays or another vital part of vaccine development?

We can help you quantify residual agents and host cell...

Do you develop or manufacture any type of vaccine? And are you looking for the most extensive vaccine characterization of batches, process steps and residual impurities? To ensure patient safety, heighten drug stability, not risk any developmental delays or another vital part of vaccine development?

We can help you quantify residual agents and host cell proteins (HCPs), confirm the biologic’s protein sequence, evaluate post translational modifications (PTMs) and resolve the intact mass of your recombinant proteins. At Alphalyse, we utilize mass spectrometry and thus offers several services for vaccine analysis and characterization of vaccine products. They cover everything from accurate determination of sequence, molecular weight, and purity to analysis of HCPs. It is both useful in your process development and final product analysis.

Even newer vaccines based on a viral matrix, such as lentiviral or adenovirus-based vectors, are susceptible to our approach for HCP analysis and structural characterization of the viral envelope proteins. The problem with HCP ELISAs is that they often do not accomplish a sufficient HCP coverage since viral vaccines are complex and often based on several host systems. Our services, however, provide you with a complete overview of the HCPs in your samples – in all host systems and all sample types, such as early harvest samples and cleaned-up clinical batches.

How we ensure you the highest quality

We perform all our tests according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. By using robotic automation throughout the sample preparation and data analysis, we guarantee quick turnaround time and the most detailed vaccine characterization on the market. And with more than 100 completed HCP projects in only 2 years, we have seen all sample and host types out there. If your host organism(s) are sequenced, we can identify and quantify every single HCP in your sample.

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

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Why are vaccine products difficult to analyze?

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.

Why is vaccine characterization important?

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.

Which methods are used for vaccine analysis?

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.

Analytical experts

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

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