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Services

Assays

Quality, potency and safety are key features in the specification of biopharmaceutical drug substances and products. Therefore, choosing the right assays for determining the consistency of production and the quality of the produced vaccines is crucial.

Intravacc provides all aspects of vaccine-related assay development, assay validation, vaccine quality control and method transfer.

 

Intravacc has a proven track record in establishing validated methods according to ICH guidelines for quality control of vaccines.  When part of a GMP campaign, the assays can be validated and transferred to the QC department to support the IMPD filing.

 

We offer the following assays:

 

Content of drug substances and drug products

      • Mass spectrometry (de novo sequencing)
      • qPCR
      • ELISA
      • Calibration free concentration analysis (biosensor analysis)
      • HPLC
      • GC
      • Protein assays (BCA, Lowry, Peterson and Bradford)

 

Higher Order Structure of proteins and viruses

      • Circular dichroism (secondary structure of proteins)
      • Fluorescence spectroscopy (tertiary structure of proteins)
      • Dynamic Light Scattering (particle size and protein aggregation)
      • Electrophoretic Light Scattering (surface charge of particles)
      • Asymmetric Flow Field-Flow Fractionation – Multi Angle Light Scattering (FFF-MALS)
      • Nanoparticle Tracking Analysis (NTA)

 

Antigenicity

      • Biosensor analysis (Biacore T200)
      • Affinity measurements of antibodies
      • Epitope mapping (biosensor analysis or mass spectrometry)
      • 2D Western blotting (Immunoproteomic profiles)

 

Impurities

      • Host cell proteins content (ELISA – mass spectrometry)
      • LPS identification and quantification (mass spectrometry or GC)
      • Residual DNA concentration (qPCR)
      • Average chain length of residual DNA from mammalian cells (qPCR)
      • Protease activity
      • DNAse activity (gel electrophoresis)

 

Excipient testing

      • NMR
      • GC
      • HPLC

 

Stability testing

      • Accelerated stability studies
      • Real time stability studies

 

Compendial Testing to USP, EP, JP

      • Appearance
      • pH
      • Osmolality
      • TCID50

 

Cell-based bioassay

      • Virus-neutralization tests
      • Specific toxicity tests on Vero cells

 

Innate assays

      • PRR activation
      • DC or PBMC activation
      • Assessment of early cytokine responses in serum

 

Humoral responses

      • Antibody levels in serum
      • Identification immunogenic antigens
      • Quantification of antibody producing plasma cells
      • Antigen specific memory B-cells by EliSpot

 

Cellular responses

      • DC-T-cell cocultures in vitro
      • Identification of quantity and quality of antigen specific T-cells ex vivo
Analytical method development
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