Search results for " analytical" in Articles / App Notes
Article
Biacore Concentration and Ligand-Binding Analyses
During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, …
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
These range from better analytical testing and product release services to better operations staff training, optimized media and improved existing quality management systems. Better process developmen…
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Robust Optimization, Simulation, and Effective Design Space
The residual variation is the root mean squared error (RMSE) from the model and includes the variation from the analytical method as well as any other uncontrolled factor when building the model.
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Taking a “Development-by-Design” Approach to Cell Therapies
A new CEO, David Mazzo, with a doctorate in analytical chemistry and experience running both private and public international biopharma companies, assumed NeoStem’s leadership in January. He sees no c…
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Quality Systems Key to Lifecycle Drug Management
In most situations it’s easier to design a new drug than to update existing analytical methods and technology, noted Ganapathy Mohan, head of global CMC at Merck, Sharp and Dohme. Global approval of a…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
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Modular Manufacturing Platforms for Biologics
Jornitz notes that there has been recent interest in the use of pods for analytical, microbial, polymerase chain reaction, and assay development, as well as interest in the use of pods for broader hea…
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Modern Manufacturing Systems Key to FDA Quality Initiative
… in development or under review by the agency, including orphan drugs and biosimilars that raise new analytical challenges. OBP now has four Divisions of Biotechnology Product Review & Research, each…
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Re-use of Protein A Resin: Fouling and Economics
Users employ a variety of analytical tools to monitor Protein A resin deterioration over time. These include lysophosphatidic acid (LPA) analysis and HETP measurement, as well as monitoring of bioburd…
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Vaccine Development and Production Challenges Manufacturers
that its development program for its meningococcal serogroup B vaccine benefited from the application of “an extensive analytical toolkit.” That facilitated in-depth characterization of both process a…