Fast Track Analysis For Pandemic Readiness: Approaches For Accelerated Adventitious Virus Testing In Viral Vector Vaccines

In the wake of the pandemic, the demand for viral vector vaccines has skyrocketed. Ensuring the safety and efficacy of these vaccines is of utmost importance, and that's where analytical characterization and quality control come into play. While PCR assays are commonly used for testing viral content and impurities, cell culture methods are preferred for adventitious virus testing. However, these methods can be time-consuming and may not detect certain viruses.

Next-Generation Sequencing (NGS) is poised as a potential game-changer in adventitious virus testing. NGS has the ability to detect a wide range of nucleic acids present in a sample, making it a promising alternative. Regulatory authorities like the FDA and EMA have already accepted NGS for virus testing in vaccines. The benefits of implementing NGS are clear - it can lead to cost and time savings compared to traditional methods. On the other hand, there are challenges in standardization, validation and bioinformatics data analysis, all of which are critical parameters in the GMP environment.

With the application of NGS, IDT Biologika has digitized and automated the adventitious virus testing by establishing a GMP-validated data analysis platform. Its design and implementation of hard- and software follow the FDA 21 CFR Part 11 Computer System Validation and GAMP 5 guidelines. After sequencing, the data is loaded, the bioinformatic algorithm taxonomically classifies the viruses contained in the sample, and at the end issues a report that provides information on whether viral contamination is present.

However, it's important to note that the presence of viral nucleic acids doesn't necessarily indicate the presence of infectious viruses. Therefore, a follow-up strategy is required. Incoming material testing is recommended, especially for vaccines manufactured with animal-derived materials. Fetal bovine serum, commonly used in cell culture, is often contaminated with bovine parvovirus, so screening of FBS batches is necessary to prevent contamination of the final drug product.

Learn how implementing NGS technology for adventitious virus testing in viral vector vaccine development and manufacturing is crucial for ensuring safety. Gain valuable insights and references for an optimized sequencing method.