Biological Potency Assays are Key to Assessing Product Consistency
Modern bioassays enable more accurate potency testing.
UK Service Providers Look to the New World
UK-based CMOs seek opportunities in new markets.
Stiffer Enforcement at the FDA
Agency officials promise swift action against violators of drug safety and quality regulations.
The Ups and Downs of the FDA Budget
Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.
Best Practices for Formulation and Manufacturing of Biotech Drug Products
How to maintain product stability and prevent particulates.
Using Fluorescence-Based Sensing to Accelerate Process Development
A prove-free system monitors accurately at very small scale.
User Viewpoints on Disposables Implementation
What end users think about single-use systems.
On the Horizon: New Expression Systems to Become Common Industry Platforms
New expression systems compete for attention.