Search results for " process" in Articles / App Notes
Article
Chromatography for the Diversified Antibody Pipeline
Jeanne Linke Northrop: How is the development we have seen in the antibody therapeutics area effecting chromatography capture that are used in antibody processing?
Eva Helding: The advantage…
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Current Techniques and Challenges Presented in Scaling Between Bioreactors
In smaller companies with fewer projects the PD team takes a large responsibility and follows the process for clinical manufacturing. On the other hand, in larger organizations with broad portfolio of…
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Mechanistic vs Statistical Models
Read on the differences between statistical and mechanistic models, and their use in improving your process development.
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How To Execute Successful Data Migrations
Which data should be migrated?
Consider a scenario in which a team will be implementing a new document management system that supports core manufacturing processes. The legacy system being r…
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The Importance of Partnering for Bioanalytical Studies
Importance of bioanalytical studies
BioPharm: Why is it so important to conduct bioanalytical studies during the development process of a new biological therapeutic?
Bose (Emery Pharma): Bio…
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Best Practices for Selecting a Top-Quality Cell Line
…e desired profile—with high manufacturing efficiency, according to Ian Collins, senior director of process development at Catalent. “A high-quality cell line should be well-rounded among the critical…
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2019 HTPD Conference is Approaching. What Happened Last Time?
HTPD 2019 will cover process development spanning upstream through downstream processing for both mAbs and Ab-like molecules, as well as novel biomolecules. Sessions will also include integrated PD an…
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Modeling the Degradation of mAb Therapeutics
Kinetic modeling can be an effective tool for establishing product stability, offering a deeper understanding of these processes and allowing developers to mitigate the risk of product degradation dur…
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A Look into the Future of Biopharmaceutical Quality
The current processes used to update procedures, systems, and filings may not be able to keep pace with the rapid introduction of technological advances. I don’t think this is new. Science has always …
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FDA Framework Spurs Advanced Therapies
Need for new manufacturing technology
Indeed, developers of new regenerative medicines will require robust platform processes, such as automation technologies and 3-D bioreactors, to maintain cons…