During the first year of the VAC2VAC project ample of process has been made. Here you can find a two page summary of the progress.
The overall objective of the “Vaccine batch to vaccine batch comparison by consistency testing” project (acronym: VAC2VAC) is to demonstrate proof of concept of the consistency approach for batch release testing of established vaccines. This means that non-animal assays - instead of animal tests - shall be used to ensure that each vaccine batch produced is consistent with a batch already proven to be safe and efficacious in registration studies or clinical trials. Hence the name “consistency approach”. It covers vaccine potency, safety and animal welfare. Due to the nature of the non-animal assays, the consistency approach also clearly will speed up the release time, so that vaccine batches will be available for vaccination much quicker.
Progress, in brief:
During the first year of the VAC2VAC project, a system for the management of samples and reagents was developed, which allowed for delivery of vaccine samples from industry partners to public partners. Furthermore laboratory work was initiated and progressed, including:
- The development of mass spectrometry assays for Leptospira and DTaP (Diphtheria, Tetanus, Pertussis) vaccines to quantify antigens in the complex vaccines
- Conformational fingerprinting (a technique that can be used to monitor vaccine quality based on the structure of the antigen)
- Development and characterisation of monoclonal antibodies to determine antigen content and quality
Cell based assays for consistency testing
- Development of assays based on vaccine mediated activation of special reporter cell lines has started
- Development of an antigen-specific antibody producing B-cell assay is ongoing
- Reporter cell lines for safety and toxicity testing are being developed
Multiparametric assays and bioinformatics
- DNA sequencing, RNA sequencing and targeted proteomics have been used to characterise a seed strain for stable and reproducible production of toxin for human vaccines.
- The development of an alternative pertussis vaccine safety test has been initiated with the goal of improving an existing cell-based assay to allow a fully quantitative readout.
- The interaction of vaccines/adjuvants with antigen presenting cells is ongoing in order to evaluate adjuvant stability and/or an in vitro potency test
Please click here for a more in depth report.