Podcast: Powder Dynamics and QbD
The QbD initiative is driving pharmaceutical chemists, formulators, process developers, and manufacturers to come to a better, more detailed understanding of the characteristics of the ingredients they’re working with and how those ingredients behave during different phases of the manufacturing process. Many of these ingredients are powdered solids, and scientists are trying to learn what they can about the characteristics of their constituent particles. This is no easy task.
Editor-in-Chief Michelle Hoffman talks to Tim Freeman, Director of Operations at Freeman Technology, about the industry’s current level of understanding about powder characteristics and dynamics.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This 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.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
