Search results for " monitoring"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Optimization and validation of a quantitative capillary electrophoresis sodium dodecyl sulfate method for quality control and stability monitoring of monoclonal antibodies. Anal Chem. 2006;78:6583–94.…
Article
Regulatory Challenges in the QbD Paradigm
In addition, investigators would review sampling and testing plans for in-process monitoring at crucial manufacturing steps in lieu of end-product monitoring, and evaluate process analytical technolog…
Article
Setting Up Bioprocessing Systems for Digital Transformation
As these data become a key part of the process control strategy, there is increasing focus on control system reliability through the risk of batch failure if the monitoring and control systems fail du…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
…l, improvements and additional capabilities are still needed to achieve true in-line/on-line/at-line monitoring (6).
More complex analyses, such as those required for protein…
Article
Modeling the Degradation of mAb Therapeutics
Size-based monitoring tools such as SEC, DLS, mass spectrometry (MS), and sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE) are commonly used to detect fragmentation and identify th…
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Managing Residual Impurities During Downstream Processing
… biopharmaceuticals--as well as improvements in analytical technology that provide enhanced means of monitoring--have, however, been key drivers for the continued review and optimization of guideline…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
The applicability of SPR in validating potential bispecific molecules for quality and in monitoring multiple binding sites is also discussed.
SPR analysis is focused on ligand binding
Ligand-bindi…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Understanding potential sources of contamination for a given facility and manufacturing process is key to planning for design, preventative maintenance, bioburden monitoring, and remedial actions. Eff…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Choose your Optimal Wavelength for Chromatography
U9-T monitor with dual wavelength monitoring at 260/280nm can also show a ratio curve, with pure proteins generally having a value of 0.6 and pure DNA/RNA a value of 1.8–2.0.
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