Summer Camp

Summer activity #2
Vaccines Focus (2/2)

 

Accelerate Your Vaccine Program with Next Generation Sequencing (NGS)

The current COVID-19 pandemic and the resulting emergency to develop vaccines against the SARS-CoV2 remind us more than ever the challenges of the vaccine industry. Indeed, the pressure for fast development and production without a compromise on safety for the patients has never been so critical. Various solutions have been put in place to speed-up development for vaccines against SARS-CoV2, such as reducing the steps before going into the clinics[1], but these are exceptions and are not solving the issue of time of production on the long run.

While safety tests are necessary to ensure the marketing of safe products, it has been reported that about 70% of the production time is due to safety tests[2]. The time to results in the compendial methods is often not in accordance with the time of production. For example, an in vivo test run on crude harvest can take up to three months to be completed[3], while the subsequent steps of production are much shorter.

A solution to reduce the production time is to develop and use faster alternative methods to some of the compendial tests. Next-generation sequencing (NGS) has the potential to replace existing assays. The worldwide regulatory authorities are adopting this technology and certain guidelines are being revised to take advantage of it. The use of high-throughput sequencing (HTS) to perform the required quality control testing in biologicals differs from current molecular approaches since its use enables an unbiased approach of detection.

As an innovative company dedicated to the quality control of biologics, PathoQuest has developed and validated proprietary protocols based on NGS to detect the presence of adventitious agents with short turnaround time. PathoQuest’s services offer is not only using the “standard-based” NGS, but it is also a unique approach with protocols specifically designed, standardized, and validated to answer each product type (raw material, cell banks, virus seeds, etc.) precise challenges and needs.

 

[1] Lurie N et al. New Eng J Med. March 30, 2020 DOI: 10.1056/NEJMp2005630

[2] https://vaccination-info-service.fr/Generalites-sur-les-vaccinations/Qualite-securite-et-efficacite-des-vaccins/Securite-et-qualite-des-vaccins#section3

[3] JP Gregersen PDA J Pharm Sci and Tech 2011, 65 634-644 doi:10.5731/pdajpst.2011.00832

Click here to learn more about PathoQuest’s Biologics Genomic Service for biopharmaceutical companies.