Search results for " analysis" in Articles / App Notes
Article
Assessing Manufacturing Process Robustness
This step will involve extensive data set collection, data set review, and data preparation for the subsequent statistical analysis.
As a result, the database must be developed so that it…
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Remote Monitoring and Big Data Advance Upstream Automation
The key component to all of this is software capable of integrating the variety of lab equipment and resulting data allowing for multivariate data analysis and process control,” he says.
Notable r…
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Impurity Testing of Biologic Drug Products
In this roundtable discussion, industry experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
Method development and validation
B…
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Continued Process Verification for Biopharma Manufacturing
In its entirety, CPV includes: preparation of a written plan for monitoring a biopharmaceutical manufacturing process, regular analysis of results, documentation of the data collected, analysis of dat…
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Essentials in Quality Risk Management
Risk assessment includes risk identification, risk analysis, and evaluation. This process is generally a team effort to work through the product/process step-by-step to identify and evaluate each pote…
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Modeling the Degradation of mAb Therapeutics
Figure 1: Aggregation: characterization, analysis, and modeling data
[All figures courtesy of the authors].
Kinetic modeling of mAb aggregation
Data obtained from SE–HPLC analysis were…
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Tackling Analytical Method Development for ADCs
Expertise in both chemical and biological analysis is required, and techniques for both types of molecules must be used. In addition to performing typical characterization studies, the linker chemistr…
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Analyzing Proteins Using SEC, MALS, and UHPLC
The combination of SEC with downstream light scattering analysis and the development of columns that can be used for ultra high-pressure liquid chromatography (UHPLC)-based SEC are overcoming many of …
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Finally, a qualitative risk analysis or a formal failure mode effects and criticality analysis (FMECA) was conducted for each of the identified process parameters. The purpose of this assessment is to…
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Digitalization: The Route to Biopharma 4.0
The industry realizes that there is a limit on the number of experiments that is feasible, and, hence, extensive use of methodologies such as design of experiments and multivariate data analysis is be…