mRNA’s rise amidst the COVID pandemic

The introduction of mRNA vaccines by Pfizer and Moderna for COVID-19 took much of the world by surprise. But for Katalin Karikó, Pieter Cullis, and Drew Weissman, among others, it was merely the culmination of decades of research and development. Implementing a novel modality during such a public health crisis took confidence, determination, and the hard work of millions of people. It didn’t happen overnight.

A stepping-stone in ongoing quality improvement

The ISO 13485 standard covers the quality management system (QMS) requirements for medical devices (like CT scanners, blood perfusion pumps, diagnostic IVD tests) including requirements for regulatory purposes. Certification is granted by a third-party registrar through an annual audit process with renewal every three years. Unlike global medical device governmental regulations, the ISO 13485 standard is the same whether you are manufacturing in Italy, Africa or the United States.

Expectations, oversight and transparency

From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.

Increased expectations, increased accountability

Rapid evolution. In short, that’s what we’re seeing in the method development and assay life cycle field. The concepts have been around for quite some time, but now with updated and new guidance for analytical life cycle and analytical method development, we’re seeing a more dynamic period emerging in the space. This includes increased expectations for analytical method development and increased accountability for reporting development data.