| New This Week on Process Development Forum |
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- Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
This work demonstrates the clearance of cereulide from mAb produced in Chinese hamster ovary cells over two purification steps.
(Read Article)
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- Preclinical Evaluation of Product Related Impurities and Variants
Two case studies show that appropriate sample preparation and customized testing using different orthogonal tools provide rich information about product safety and efficacy.
(Read Article)
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- FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate the development of cell and gene therapies.
(Read Article)
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Questions for 2018
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