Search results for " report" in Articles / App Notes
Article
An Analytical Approach to Biosimilar Drug Development
In addition, these analytical tools are required to be more accessible and automated to conduct acquisition, processing, and reporting from characterization and comparability studies that are needed f…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
In characterization, complete binding curves are normally fitted to defined interaction models to provide affinity and rate constants, whereas report points indicative of binding and stability of bind…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
CBER is receiving dozens of applications to test new gene therapies, Marks reported at the Cell and Gene Therapy symposium in July 2018, sponsored by CASSS. He acknowledged that the logistics of manuf…
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A Look into the Future of Biopharmaceutical Quality
This may present challenges for some organizations associated with the collection, processing, reviewing, and reporting of data and ensuring the accuracy and consistency of analytical results. The acc…
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The Challenge of Disruptive Technologies in Bioprocessing
BioPlan Associates, 14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (BioPlan Associates, Inc., Rockville, MD, April 2017).
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Today, however, cell titers have been reported at levels in excess of 10 g/L, he says.
This resulted from the introduction of parental cell lines better suited to modern fed-batch processes and…
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Putting Viral Clearance Capabilities to the Test
The studies must be designed to evaluate potential viruses, be representative of the production process, meet regulatory requirements, and provide reportable data. In addition, the testing should be c…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Rita Peters, editorial director of BioPharm International, shares observations of the magazine’s editorial team as they reported on industry developments at the April event.
Q: What insight did F…
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Freedom to Roam During Protein Purification Runs
You may want to plan for the next run, analyze previous runs, prepare a presentation or work on your next publication or report. But while you focus on other activities, you still need to monitor the …
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Navigating Data Integrity in the Modern Lab
The technology of the past decade has allowed for better preservation of data, from the time of capture in electronic format through to its analysis and use in reports.
This digital thre…