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.
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
The Value of Primary Working Standards in Pharmaceutical Quality Control
September 3rd 2022It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.