Search results for "virus clearance"
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The Development and Application of a Monoclonal Antibody Purification Platform
In these cases, there were occasional issues surrounding virus clearance, raising safety concerns especially for antibodies required in large doses. To address these issues and increase the robustness…
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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From Darwin to Recombinant Fc Multimers
…and Zika virus, two recent emerging pathogens, and studies confirming the effectiveness of existing virus clearance steps against these pathogens. Dr. Roth stressed how important it is to maintain th…
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Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. I…
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Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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Report from the 6th International HTPD Conference
Another presentation during the modeling session that gained interest was Lukas Döring from Rentschler, who talked about the possibilities to use mechanistic modeling for virus clearance studies. Inde…
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Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
2019 proved to be an exciting year for biopharmaceutical developers and process engineers, filled with both advancements and lessons. Considering how far the industry has come, what direction will 2…