Metrolab Blog

Supporting COVID-19 Vaccine Developers with Rapid Sterility Release Testing

 

Rapid Vaccine Production Requires Rapid Sterility Testing

While pharma and biotech firms race to develop a cure for Coronavirus SARS-CoV-2 (COVID-19), the need for rapid testing to ensure a vaccine is safe, effective, and accepted by regulatory authorities is critical. Every vaccine and injection that is administered to patients is required to be deemed sterile through final product sterility testing.

In preparation for mass production and global demand, manufacturers and governments are beginning to seek faster solutions ahead of regulatory approval of a COVID-19 vaccine.

What is Rapid Testing?

Sterility Testing is reduced from 14 days to 6 days and in-process testing is reduced from 4–7 days to 24 hours.

The Celsis®rapid sterility testing platform consists of instruments, reagents, pre-qualified test consumables, and a unique validation service support package to fast track the time to regulatory approval.

horseshoe crab

 

Two instruments built on the same technology platform, but with options for high throughput manufacturing and sample throughput and lower sample throughput.

  • Celsis Advance II System: 120 assays/hour, ideal for large-scale production and manufacturing quality control testing
  • Celsis Accel System: 30 assays/hour, ideal for smaller organizations or supporting process development testing

See more here