Search results for " equipment" in Articles / App Notes
Article
FDA Seeks Metrics to Define Drug Quality
…of poor process control, poor training of operators, lax oversight by supervisors, poorly maintained equipment and facilities, or poor product and process characterization, according to the Generic P…
Article
The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
This application note describes the performance of single-use Xcellerex XDM Quad Mixing System used as a slurry tank when packing chromatography columns. The capability of the mixing system to keep …
Article
Essentials in Quality Risk Management
All unit operations, formulations, analytical methods, excipients, cell banks, working cell banks, equipment, reagents, chemistry, facilities, and materials are evaluated for the potential influence t…
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…