NEWS & SUMMER ACTIVITIES
The reduction, refinement, and replacement of animal testing in the drug development process also known as the 3R initiatives is not only a hot topic for the industry but also for a wider audience. The regulatory authorities are supporting the development of alternative methods to animal testing
See how next-generation sequencing can supplement in vivo testing for quality control programs, it is a robust and accurate alternative that can save industrials time and money.
In a challenging regulatory environment, the industry should ensure the integrity of cell cultures used in research.
A new approach based on next-generation sequencing has been gaining steam as the most comprehensive tool to demonstrate the clonality of production cell lines.
Watch out how! >>
Current adventitious virus detection, such as, in vivo, in vitro assay, or PCR have their limitations. New alternatives are now available, they can be more powerful, faster, and most of all more robust. Waiting for ongoing regulatory-driven studies’ results, check out this 2019 collaborative study. It highlights how PathoQuest’s Transcriptomic approach can differentiate living viruses from carry-over while being compared to PCR assays. Receive a free hard copy of the Biologicals article here>>
Next-generation sequencing (NGS) is a fast and reliable quality control test for adventitious agents’ detection and viral stock characterization. It has the potential to supplement or replace the actual methods.
Bio-manufacturing enters a new phase, regulations are being revised to take advantage of NGS. Check-out how with this regulatory focused webinar replay: the replay of “The Benefits of NGS-based Quality Control for routine Biologics testing Using GLP-Certified solutions”.
From vaccines to cell & gene therapies and monoclonal antibodies, ensuring the safety of the products is a major concern when it comes to the development of biologics. Next-generation sequencing (NGS) has the potential to help the industry to derisk its processes but is often dismissed because of its false-positives rate.
This article reviews how a validated NGS approach can lift the false-positive issues and thus making it the perfect solution to enhance the time to release.
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.
This short article reviews how NGS is the perfect solution to speed-up the development of new vaccines.
The impact of COVID-19 has highlighted the biopharmaceutical industry’s need for fast & innovative solutions to accelerate the development and production of vaccines.
Next-generation sequencing (NGS) is a performant, validated, and secure method that brings significant advantages in terms of turnaround time, safety, and cost-effectiveness to the vaccine production process.
This 25 min long webinar reviews QC tools to mitigate risks and comparison of NGS with other available methods.