Search results for " capacity" in Articles / App Notes
Article
Best Practices in Adopting Single-Use Systems
Potential adopters must focus on which criteria to consider as their plant’s manufacturing capacity evolves away from multi-use unit operations to disposable components and systems.
Bioproce…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
Article
Stirring up the fermentation game
Bioreactors designed for production in mammalian culture fall short of meeting these unique requirements, for example in terms of oxygen transfer capacity and temperature control. The Xcellerex XDR-50…
Article
Advancing QbD in the EU
EMA also thought that details of the "pre-planned inclusion of failsafe manufacturing site capacity" should possibly be included in marketing authorizations. In the longer term, the agency is consider…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
Each synthesizer has the capacity to synthesize two oligomers, typically 6500 KD to 7500 KD in size, per 24-hour cycle at scales ranging between 10 μmol to 800 μmol. Following a manual deprotection of…
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…