Search results for " system"
Article
Elucidating Biosimilars Characterization
…although these processes can be well-defined, they are subject to the variability inherent in living systems. The active ingredient for biologics can only be considered similar, not identical.
Pr…
Article
QbD and PAT in Upstream and Downstream Processing
However, it is important to consider the CQAs in a matrix since one knows that a biological system has the capability to compensate or adjust its metabolic pathway.
Vanden Boom (Hospira): The enha…
Article
PDA's Technical Report for Biotech Cleaning Validation
It demonstrates that the cleaning process adequately and consistently removes product residue, process residue, and environmental contaminants from the cleaned equipment or system, so that this equipm…
Privacy Policy
It can also include the collection of “Non-Personally Identifiable Information” through tracking systems. This includes information about your devices, including your IP address, location of the devic…
Article
Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
Article
Impurity ELISA automation for faster process development
This blog highlights how Cytiva impurity ELISA kits are easily integrated into automated systems such as the Biomek i5 to increase throughput, while maintaining the same robust and sensitive results y…
Article
Instructional Videos for Bioprocess Equipment
Cytiva offers free on-demand instructional videos that will help you with operating bioreactors, chromatography and filtration systems, including flow kit installation on single-use systems. Modules a…
Article
Moving Biosimilars Forward in a Hesitant Market
…automatically deemed to be interchangeable with its reference product, similar to the EU designation system. I think that would ease the burden,” Gabrielson says.
Easing the way for market uptake…
Article
Paring Down Impurities in Downstream Processing
Biopharmaceutical expression systems range from yeast and insects to mammals and plants. Bioreactors to house these systems might be stirred-tank, air-lift, fixed-bed, hollow-fiber perfusion, or suspe…
Article
Report from the 6th International HTPD Conference
The presentation concluded with an outlook of future research areas which included intelligent automated system for the whole vaccine manufacturing process, for short notice development to support nex…