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…

Article 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…

Article 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…

Article 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…

Article 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. …

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

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