01.31.23 -- How Well Are Your HCP ELISAs Covered?

Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.

Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

Tangential flow filtration (TFF) is a rapid, efficient method for separating and purifying biomolecules. Learn about TFF, typical TFF system configurations, ultrafiltration fundamentals, applications, system selection considerations, and more.

We discuss the challenges and opportunities when developing a media approach and explore the benefits of partnering with a provider with expertise throughout the media pipeline.

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.