Search results for " detection"
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
Article
Finding the Needle in a High-Dimensional, Information-Rich Data Haystack Can Be Time Consuming
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Biacore™ surface plasmon resonance (SPR)-based sensors are an essential tool in drug discovery. With these tools, scientists can detect and characterize low molecular …
Article
Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can enhance…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Thus, for glycoform, host-cell protein and DNA, protein aggregation/fragmentation, endotoxin, and many other analyses that rely on an array of off-line separation and detection technologies, there are…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
… design to accommodate single use and minimize any possible cross-contamination while still allowing detection and prevention of possible deviations.
Equipment selection matters too
In genera…
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Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
Article
Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
Article
Tools and Processes for Mature and Emerging Therapies
New technologies and thought trends provide innovative biomanufacturing approaches for a range of therapies.
By Rita Peters
Conference sessions and new technology introductions at recent t…
Article
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
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Biomanufacturing proc…