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
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
This article summarizes several recent advances in glycoanalytics that have addressed many of the issues facing exoglycosidase use. These recent innovations are better positioning exoglycosidases for …
Article
Reimagining Affordable Biosimilars
Advances in preclinical development
Analytics
The complexity of biotherapeutic molecules, in particular monoclonal antibodies (mAbs), lends themselves to fascinating targets for analytical…
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…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…