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 and Acceptance Criteria for Biotechnological/Biological Products.

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

Identification

We identify the exact content of your vaccine product by mass spectrometry.

Peptide mapping

We confirm the theoretical amino acid sequence of the recombinant protein by peptide mapping.

Sequencing

We determine the exact amino acid sequence of proteins by Edman or de-novo sequencing.

Molecular weight

We determine the exact molecular weight of your recombinant proteins.

Quantification

We quantify each protein and also the total protein content of the product.

Modification

We determine the number and also the position of disulfide bridges and glycosylations in your product.

HCP analysis

We identify and quantify host cell proteins in your product and provide physical properties of each HCP.

Vaccine analysis

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

Send us your project description so we can design a service package that meets your needs.