Search results for "analysis"
Article
Going Small to Achieve Success on the Commercial Scale
“Demonstration of both individual unit and linked unit output (recovery, product quality attributes, product purity, chromatographic profiles/transition analysis, etc.) comparability between small and…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Global & USA BioSimilar Market Analysis Report 2015-2021, Research and Markets, http://www.prnewswire.com/news-releases/global--usa-biosimilar-market-analysis-report-2015-2021-300134719.html, accessed…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The growth of the segment has necessitated development of new efficient and cost saving platforms for the preparation and analysis of early candidates for faster and better antibody selection and char…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
… process: biological reagents and reference materials, study design, laboratory protocols, and data analysis and reporting (3). Although each contributes to a systemic problem that requires extensive…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
… testing various experimental conditions in a parallel manner, analyzing data using high-throughput analysis, and evaluating data and analyzing the results.
Design of experiments (DoE) provides a…
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…