Vaccine Immunogenicity Testing

Product – IBR Inc., Institute for Biopharmaceutical Research
Vaccine Immunogenicity Testing

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Contact Supplier: IBR Inc., Institute for Biopharmaceutical Research
Supplier Product: Vaccine Immunogenicity Testing
Address: Lauchefeld 31, CH-9548 Matzingen, Switzerland
Tel: +41 52 366 3520
Fax: +41 52 366 3521

Vaccine Immunogenicity Testing

IBR Inc. provides quality efficacy and safety vaccine testing along with expert regulatory guidance. Testing the effectiveness and safety of a vaccine is essential and therefore evaluating the immunogenicity of a vaccine is necessary. Vaccine immunogenicity assays are needed to measure immune responses and identify correlates of protection. IBR Inc. has extensive experience in the development and validation of a wide range of analytical assays that are applied in different stages of vaccine development whilst always keeping in line with regulatory and scientific requirements offering GLP compliant vaccine testing for non-clinical and clinical studies.

IBR Inc. offers a large range of techniques and validated methods for vaccine testing.

Vaccine Testing:
• Non-clinical and clinical studies
• Cellular and humoral immunology – characterization of the humoral and cellular immune response (anti-drug Abs, neutralising Abs, CD4/CD8, B-cell response)
• Functional in-vitro tests
T and B cells – Immune responses after vaccination (phenotyping, cytokine release). Effect of vaccines on activation of innate immune system
Human PBMC – Isolation, proliferation, cytotoxicity, bacterial killing, phenotyping, cytokine release, gene expression
Residual DNA – Proprietary HPLC method to cover the Draft FDA guideline (February 2010) on quantification of residual genomic DNA according to size (>200bp) in final vaccine drug products and in-process samples
• Bioanalysis of antibodies in animal and human samples – method development, validation and sample analysis
• Determination of bacterial killing by Opsonophagocytic Assay (OPA) using a validated automatic colony counter
• Biomarker analyses (FACS, ELISA, RT-PCR, immunohistochemistry, RNA/ Protein) in fluids, tissue sections, biopsies
• Molecular biology – cloning, PCR, RT-PCR, DNA preparations, RNAi knock down, etc
• Bioactivity of cytokines
• Endotoxin testing

IBR Inc. has developed assays to quantify Host Cell Proteins:
• Generic and host cell-specific ELISA combined with 2 D Gel Western Blot analysis -method development, validation and sample analysis

• Haemolytic activity and Complement activation – method development, validation and sample analysis
• Enzyme activities – method development, validation and sample analysis

Cell Based Assays
• Analysing the influence of Biologics or Small Molecules on cells – (proliferation, migration, adhesion, cytotoxicity, apoptosis, phenotyping, gene expression, signaling) using PBMC, granulocytes, fibroblasts, endothelial cells and more – method development and validation

IBR Inc. has a track record of successful submissions of study reports globally including successful project submissions to the FDA, EMA, Swissmedic, TGA and Turkish Authorities.

For more information or to discuss vaccine immunogenicity testing please contact IBR Inc. directly.

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