Search results for " analytics"
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Process analytics for purification of monoclonal antibodies. J Chromatogr B. 2007;848:79–87.
16. Farnan D, Moreno GT. Multi-product high-resolution monoclonal antibody charge variant separations b…
Article
PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
By Cynthia A. Challener
jijomathai/stock.Adobe.comAnalytical instrument…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Summary
Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in industries where consistency and accuracy are of paramount importan…
Article
Reimagining Affordable Biosimilars
With use of “omics” tools, big-data analytics, bio-mathematical modeling, and in-silico and in-vitro tools, there can be a transformation in the preclinical development of biosimilars.
Reference…
Article
Moving PAT from Concept to Reality
Hence, these processes benefit from a stricter control strategy, where high levels of automation and implementation of PAT and advanced data analytics play a key role,” Grieb asserts.
Essential fo…