May 7th 2025
This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Industrializing Design, Development, and Manufacturing of Therapeutic Proteins
May 1st 2011The authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.