Search results for "analysis" in Articles / App Notes
Article
Breakthrough Drugs Raise Development and Production Challenges
The initiative, he noted, requires risk-based assessment strategies and a product quality lifecycle management plan, combined with clear analysis of what can be evaluated during review, and what can b…
Article
A Bright Future for the Plasma Fractionation Industry
Process risk analysis was carried out to establish linked process parameters, and after robustness studies, the critical process parameters (CPPs) were determined. The advantages of this QbD approach …
Article
Continuous Chromatography: Trends, Definitions and Approaches
However, based on our analysis, 3- and 4-column systems will be sufficient to cope with most industrial applications. For the very low titer processes, or rather for the cases where the ratio of capac…
Article
Re-use of Protein A Resin: Fouling and Economics
These include lysophosphatidic acid (LPA) analysis and HETP measurement, as well as monitoring of bioburden, endotoxin, host cell proteins, and media components in the pool over resin lifetime.
Fa…
Article
Continuous Manufacturing: A Changing Processing Paradigm
The company’s continuous “Next-Generation Biomanufacturing Facility” uses single-use bioreactors, disposable plastic containers, real-time quality analysis, and also boasts modular design. It is expec…
Article
The Bullish Outlook for Biosimilars
Research and Markets, An essential competitor analysis report on human growth hormones (hgh): biosimilar pricing is not enough, convenience will mandate (October 2008).
14. Pharma and Healthcare I…
Article
Fermentation for the Future
“From a process perspective, soluble expression is also beneficial for establishing automated bioprocessing with cultivation and purification closely linked and supported by timely analysis,” Reinisch…
Article
Securing the Single-Use Supply Chain
…les under typical use conditions obtained from two suppliers to Chemic Laboratories for comparative analysis of their extractable/leachable profiles. “Tubing was selected for this exercise because it…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
…s, and overhead to pack a glass column on site and prepare it for use in a GMP suite with a similar analysis for the acquisition of a prepacked column. In collaboration with Dr. Howard Levine from Bi…
Article
New Era for Generic Drugs
Although there is general agreement that in-depth analysis of product structure and function plus pharmacology testing can combine to document similarity, there’s much disagreement over extrapolation …