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Applying Quality By Design Methods To Chromatography
By Dr. Jonas Anders, Head of Marketing Chromatography, Merck Millipore |
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Quality by Design (QbD) methods have been used to improve processes across a variety of fields. The biopharmaceutical sector has recently embraced these methods, with the FDA advocating their use, to ensure consistent product quality and lower product development and manufacturing costs.
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Featured Articles |
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A Novel Protein Aggregation Assay For Biologics Formulation Studies And Production QA/QC
By Peter Banks, BioTek Instruments, Inc.; Wayne Patton and Dee Shen, Enzo Life Sciences
Biochemical assays for monitoring protein aggregates often rely upon ultracentrifugation, size-exclusion chromatography, gel electrophoresis, dynamic light scattering, or turbidity measurements. Read more.
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Characterization Of POROS® MabCapture A™ Chromatography Media
By Christine Gebksi, Susanne Surka, Thomas Leete, et al, Applied Biosystems
As cell culture technology improvements continue to result in monoclonal antibody expression level increases, the protein manufacturing throughput bottleneck has shifted to downstream purification. Read more.
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Greater Loading Capacity And Resolution For Improved Productivity In Peptide Purification
By Dr. Reno Nguyen, Grace Process Purification Specialist
Peptide therapeutics have been recognized as delivering the best of both worlds in terms of small molecule synthesis efficiency and biologics efficacy and reduced toxicity. However, challenges in mass production and low oral availability have historically made them less than ideal drug candidates. Read more.
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Featured Multimedia |
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Video: Packing CHT In The Bio-Rad Inplace Column
Ceramic hydroxyapatite, or CHT, is a versatile chromatography support used for the separation of biological molecules including polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins.
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