Search results for " methods"
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Quality by design for biotechnology products—part 1
Nevertheless, the risk of immune response to a fully human antibody and other self proteins necessitates screening therapeutic protein candidates for immunogenicity using in silico methods, and in vit…
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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
“It is not unusual for changeover to require weeks to complete when traditional methods are followed. With the changing industry tide favoring multiproduct manufacturing facilities, methods to enhance…
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New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
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Best Practices for Selecting a Top-Quality Cell Line
“Additionally, Cai notes that bioinformatics methods can help rationally design a host cell through determination of ideal genome sites for target integration and pathway engineering based on RNA seq…
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A Look at the Affinity Chromatography Landscape
“These developments have made the purification of certain vectors much more efficient and consistent than previously achievable with traditional methods,” he observes. In addition, Baker notes that ma…
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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
“In its simplest form, a process is a blending or a transformation of inputs such as people, materials, equipment, methods, and environment into outcomes. Some of these inputs do the transforming and…
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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 (…