Search results for " analytical"
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
To develop intensified processes, analytical technologies are needed to assess how those processes are behaving in real-time, or close to real-time, to understand if the process is proceeding as inten…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
By taking a holistic approach to improving the analytical process, one can identify strategies to increase throughput and reduce development times and the costs of analytical methods. This article dis…
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PDA's Technical Report for Biotech Cleaning Validation
The exception is when principles of process analytical technology are used for process control. These parameters are also interrelated. For example, a cleaning process may be effective at a high tempe…
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Impurity Testing of Biologic Drug Products
“Aggregates are of particular concern, either in soluble dimer/oligomer form or subvisible particle form,” notes Jay Kang, director of analytical and formulation development at Patheon, part of Thermo…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sa…
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Nurturing Knowledge from Disparate Data Streams
In addition, despite advances in the digitalization of analytical data, significant human intervention and manipulation is still required during any decision-making process based on data acquisition. …
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Several enzymes with precise specificities have emerged over many years as the glycobiology field’s preferred analytical exoglycosidases (see Figure 1B). These enzymes can be used individually or in c…
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Reimagining Affordable Biosimilars
With the ever-growing therapeutic modalities (such as bi-functional molecule, antibody-drug conjugates, cell and gene therapies) (1) along with advanced analytical tools to measure primary, secondary,…
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Moving PAT from Concept to Reality
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors needed for the measurement of critical product quality attributes and product-related species are not commercial…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…