WHO Proposes Reference Standard For Adventitious Virus Detection
Emerging global standard could speed testing of biologics and gene therapies for stray viral particles, while sparing laboratory animals.
You may also be interested in...
Next-Generation Sequencing For Adventitious Virus Detection Helps Speed Response To COVID-19
It's another case where the pandemic spurs adoption of ways to speed the manufacture of vaccines and biologics that have been in development for years.
US FDA Expects Updates On Investigational Gene Therapy CMC Improvements
Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.
FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution
New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.