Potency assay development uses DoE and QbD to improve accuracy, consistency, and regulatory readiness in biologics testing.

A new Armatus publication summarizes a novel potency assay platform to advance gene silencing therapies for rare neuromuscular diseases.

A good assay, they say, is the stuff of good science. Whether it’s a whole new type of test, a twist or a tweak of an old one, or a way of combining things that hasn’t been worked out before, assay ...

Miniaturization has become a key strategy in modern assay development — reducing reagent consumption, increasing throughput, ...

Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help industry develop and validate immune assays for the assessment of the immunogenicity of therapeutic protein products ...

NEW YORK, NY, UNITED STATES, April 27, 2026 /EINPresswire.com/ -- With years of experience in the pharmaceutical and ...

Allogene Therapeutics has announced an expanded collaboration with Foresight Diagnostics to develop a minimal residual disease (MRD) assay as a companion diagnostic tool for identifying patients with ...

The global pandemic has increased focus and scrutiny on molecular diagnostic assay development, resulting in a need for assays that provide quick results while delivering expected performance and ...

In this interview, Michael Nilsson, the Assistant Director of Liquid Handling at FORMULATRIX , talks to News Medical about simplifying assay development and optimization and the different instruments ...