Search results for " analysis"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these methods can reduce analysis and development time and thus accelerate the progress of therapeutic proteins toward the clinic.
REGULATORY EXPECTATIONS FOR THE ANALYSIS OF MA…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Therefore, NIR does not provide specific identity of the studied material and requires a use of spectral libraries or multivariate data analysis (MVDA) for spectra evaluation. NIR spectroscopy is a ve…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
While CQA analysis is typically performed in a core analytical lab, there are also other in-process controls that allow a manufacturer to steer the process toward a product with known quality. For eac…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Biomolecular interaction analysis (BIA) can be used in the following ways (3):
To monitor the level of interactions between two or more species
To determine the affinity of the in…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Although the criticality of some attributes at this stage may still be somewhat based on speculation, these “potential CQAs” (pCQAs) serve as both a baseline for development to proceed and a gap analy…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Techniques for glycosylation analysis
N-glycosylation occurs when the carbohydrate is attached to asparagine in the consensus sequence asparagine-X-serine/threonine, where X is any amino acid excep…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This article presents the first part of a practical roadmap that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process valid…
Article
Virus-like Particles as Therapeutic Moieties of the Future
For simplicity, the analysis can be categorized into compositional, morphological, functional, and stability based.
VLP composition analysis
Depending on the parent virus, VLPs m…
Article
Moving PAT from Concept to Reality
In-line sensors are placed in a process vessel or process stream to conduct the analysis in-situ. On-line sensors are connected to process side streams and perform periodic automatic sampling, returni…