Search results for " control" in Articles / App Notes
Article
What’s New in Upstream Technologies
Additionally, the new sensor technologies and the transmitter are fully compatible with the Emerson DeltaV control system.
Buffer delivery component
MilliporeSigma’s BioContinuum Buffer Delive…
Article
Scaling Up Novel Therapies
Bioreactor manufacturers now integrate analytical technologies such as sensors, which allow better prediction and control of changes between scales, into their products. Chromatography and filter manu…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
UND is undigested control. M3 is conserved trimannosyl core N-glycan.
While exoglycosidases ensure the highest accuracy in glycan structure determination, there have been several historical pro…
Article
Unifying Continuous Biomanufacturing Operations
…balanced with potential new errors related to handling disposable perfusion equipment and the proper control of perfusion.
Karst et al. highlighted a compelling reason to consider adoption of con…
Article
Single-use Bioreactors Have Reached the Big Time
Automation and process control, both of which are essential to enabling consistent and reliable biomanufacturing, have improved greatly for single-use bioreactors as well. “Historically, single-use te…
Article
Ensuring Sterility in Small-Scale Production
For these small-scale batches, manufacturers need to adhere to the recommended requirements for control of the environment as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Asso…
Article
Real Time Continuous Microbiological Monitoring
By Claudio Denoya
Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a current good manufacturing practice (cGMP)-manufacturing environmen…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
This test compares the spectrum of each media with the spectrum of each corresponding control and was successfully employed for identification of different types of growth media with diverse formulati…
Article
Biopharma Advances Demand Specialized Expertise
The complexity of product changeovers is reduced by single-use technology, which decreases the need for clean-in-place, steam-in-place, and quality control testing. Typically, line clearance time is r…
Article
Challenges in Analytical Method Development and Validation
So at this point, it is important to have confidence in the method and its ability to be transferred from R&D to quality control or, in some cases, to a contract organization that will be doing the te…