Search results for "analysis" in Articles / App Notes
Article
Managing Biomanufacturing Capacity Expectations
…ket cost to develop a new compound was found to be $2870 million (in 2013 dollars), according to an analysis by DiMasi et al. that appeared in the May 2016 issue of the Journal of Health Economics (5…
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…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Careful analysis of the combined effect of both stimuli on the cells and on the subsequent processing of the product, however, is necessary. Apart from concerns raised by the use of proteolytic enzyme…
Article
Framing Biopharma Success in 2016
Analysis of the pharma industry’s performance in generating return on investment in new drug development revealed a continuing pattern of declining returns, from 10.1% in 2010 to 4.2% in 2015. While t…
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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…
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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…