Search results for " method" in Articles / App Notes
Article
Quality by design for biotechnology products—part 1
This approach encourages incorporating prior process and product knowledge and experience-based methodologies (i.e., platform knowledge) into manufacturing throughout the life of the product.
The …
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Updating Viral Clearance for New Biologic Modalities
Generally, viral clearance methods for these processes remove known impurities, such as DNA and HCP, by using assays that were developed and evaluated for a specific cell line, says Berrie. Thus, for …
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Strategizing for Rapid Changeovers in Biologics Manufacturing
The traditional method of completely stripping down all equipment and installing dedicated materials and components for each product has proven to be a cumbersome and costly process for multiproduct f…
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New Therapies Present Scaling Challenges
Currently, viral vectors are a popular method used to deliver gene therapy. Mammalian cells are cultivated to produce the viral vector “package”, and—as in cell culturing for mAbs—cell density can be …
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Best Practices for Selecting a Top-Quality Cell Line
“Whichever method is used for clonal selection should be well validated and ideally utilized in programs that have gained regulatory approval,” he states.
The sharp increase in the complexity o…
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A Look at the Affinity Chromatography Landscape
Beyond impurity removal for “simple” proteins
Affinity chromatography in biologics manufacturing has typically served as a method for removal of process-related impurities such as host-cell protei…
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A Look into the Future of Biopharmaceutical Quality
An example is the applicability of pharmacopeial methods for product testing. Many monographs utilize traditional high-performance liquid chromatography (HPLC) for testing. Companies have migrated to …
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Biopharma Seeks Balance
Now that personalized therapies have arrived, the biopharma industry must adopt new development processes, delivery methods, processing steps, and pricing schemes, and expand patient and physician edu…
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Understanding Validation and Technical Transfer, Part I
One dictionary definition is “a particular method of doing something, generally involving a number of steps or operations” (15). Another definition is “a series of actions that you take to achieve a r…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
The experts examined possible mechanisms and technologies for improving methods and capabilities for measuring CQAs and for setting standards to help advance development of these promising therapies (…