Search results for " stability"
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Mallya, “Validation of Analytical Methods,” presentation at the Stability Conference of International Pharmaceutical Association of Canada (New Brunswick, NJ, May 2013).
22. N. Afonina, L. Bhattac…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Kinetic analysis at different temperatures provided additional information on the temperature stability of the selected fragments with respect to affinity. Chimeric chicken/human Fab fragments were sc…
Article
Platform Approach Speeds Process Development
Analysis of cell line stability and product quality is included to select the best-producing high-quality production clone.
The commonly used host cells for cell line generation are the FDA-accept…
Article
Biacore Concentration and Ligand-Binding Analyses
…tor (FcR) analysis is reviewed along with the use of these assays for assessment of drug potency and stability.
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Article
The Metrics of Quality Culture
For product-quality metrics, companies should consider reporting on batch-specific data such as trending drug product, drug substance, and stability test results against customer complaint rates. Indi…
Article
Best Practices in Qualification of Single-Use Systems
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Further investigation of binding capacity and selectivity was limited to the known pH limits for the stability of the mAb being tested.
Figure 1: Results of static binding capacity (SBC) screening …
Article
Breakthrough Drugs Raise Development and Production Challenges
Agency reviewers are agreeing to less stability data at submission, accepting amendments during the review cycle, and increasing postmarketing commitments to cover residual risk, explained Dorota Mate…
Article
Host-Cell Protein Measurement and Control
Certain HCPs with proteolytic activity can also affect drug product stability and efficacy if not adequately removed or inactivated (4). HCPs have the potential to affect both the safety and efficacy …
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Likely measures include right-first-time rate, quality-related complaints, invalidated out-of-specification results, recalls, and stability failures.
Agreement on metrics has been tricky, though, a…