R&D Services

Assay Development and Testing

At Vaxfarm we develop product specific assays those complies specific regulatory requirements. We provide a comprehensive analytical support service customised for our client.

We offer a broad spectrum of analytical assays for both process development and quality control (QC) that characterize and determine:

• Potency (for example genome copy titer, infectious titer [TCID50, EID50, Plaque Assay, ICC], ELISA titer,; other product-specific potency assays)
• Identity (for example by PCR, RT-PCR, Western blot, SDS-PAGE, restriction-enzyme mapping)
• Contaminants (endotoxin, bio-burden)
• Process residuals (e.g. host cell protein ELISA, host cell DNA by qPCR, BSA ELISA, Benzonase ELISA, and others
• Physico-chemical assays (pH, osmolality, residual moisture)
• Other compendial assays (appearance, CCIT, extractable volume, visible particles)