Search results for "analytical" in Articles / App Notes
Article
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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Reviewing the Importance of Biosimilarity and Interchangeability
However, bringing a biosimilar to market has strict challenges because the biosimilar developer must have a large set of analytical similarity data compared to the innovator biologic. In addition, the…
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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
Analytical and functional evaluation of the quality attributes of a biotherapeutic product is an integral part of process development (see Figure 1). This characterization is typically followed by pre…
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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…
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Biosimilars to Drive Modern Manufacturing Approaches
FDA officials are emphasizing how advanced analytical methods can document product performance similar to a reference drug, and that cutting-edge technology can ensure reliable production of high-qual…