Search results for " stability" in Articles / App Notes

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. Download the white paper.

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…

Article Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing. By: Randi Hernandez Whil…

Article Optimizing Resin Performance with Disposable Chromatography Solutions
Where we have seen significant advances in chromatography is with innovative new Protein A-derived media that are delivering improved capacity and stability, helping to increase production efficiency,…

Article Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission. By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh BioPharm Inter…

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