Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers.

4 Steps to Prepare for USP <800> Compliance

April Cloutier, FG Clean Wipes

A sea change in safety regulations is coming to healthcare, are you ready? The following overview briefly illustrates four of the major steps you will need to take for USP <800> compliance.

Uncle Application Compendium

Unchained Labs

Uncle is a multimodal protein characterization platform with 12 applications—allowing for measurements of stability, aggregation, and sizing from a small volume of sample.

Early Product Characterization Mitigates Risks in Biologics Development

Daniel Galbraith, PhD, MilliporeSigma

What are the structural attributes of the drug? How does this drug function biologically? Learn how examination of product attributes using high resolution techniques answers critical questions early in drug development.

Precise Subvisible Particle Analysis with 10x Less Sample

Halo Labs

In this application note, we describe three independent studies that test the HORIZON^® system’s ability to conduct rapid, low-volume, and sensitive subvisible particle analysis of different biopharmaceutical formulations. Subvisible particle analysis with less than 25 µL of sample makes it possible to take precise measurements early in the formulation process when sample is scarce.

AAE Empowers HCP Identification by MS

Jared Isaac, Eric Bishop and Ken Hoffman, Cygnus Technologies

Antibody affinity extraction (AAE) and mass spectrometry (MS) integration enables comprehensive host cell protein (HCP) analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.

Real-Time Water System Microbial Monitoring

Akash Trivedi, Mettler-Toledo

Real-time microbial detection offers transparency to pharmaceutical manufacturers for tighter process control. This whitepaper shows how a leading biotechnology company identified water system contamination and quickly brought it under control.

Is Your In-House Strategy Ready for the Uncertainties of Biologic Drug Development?

John Ward, vice-president, Engineering, Thermo Fisher Scientific

The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade—from 10% to 27%.