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Tools for Continuous Bioprocess DevelopmentIn semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.
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Mixing Time as a Criterion for Scale Translation of Cell-Culture ProcessesThe authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.
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Mixing Time as a Criterion for Scale Translation of Cell-Culture ProcessesThe authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.
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Antibody Production in Microbial HostsThe authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
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Advances in Assay Technologies for CAR T-Cell TherapiesRapid methods to test CAR-T therapies for potential contamination are on the horizon.
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The Use of the ATF System to Culture Chinese Hamster Ovary Cells in a Concentrated Fed-Batch SystemCell concentrations and resulting protein concentrations are higher in a concentrated fed-batch process than in a standard fed-batch culture system.
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Contract Services Spending: Who's Spending What, and Where?A survey provides insight into drug companies' plans for spending on outsourced services. This article contains bonus online material.
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Nature vs. nurture: Rapidly assess the impact of cell culture conditions on mAb quality and productionWebinar Date/Time: Mon, Dec 4, 2023 11:00 AM EST
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Use of an E. coli pgi Knockout Strain as a Plasmid ProducerThe authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.
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Use of an E. coli pgi Knockout Strain as a Plasmid ProducerThe authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.
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Use of an E. coli pgi Knockout Strain as a Plasmid ProducerThe authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.
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Use of an E. coli pgi Knockout Strain as a Plasmid ProducerThe authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.
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An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical ApplicationsSingle-use TFF offers the greatest savings in clinical and contract manufacturing, where the scale is low and changeovers are frequent.
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial ApplicationsThe authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial ApplicationsThe authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment ChallengeThe necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment ChallengeThe necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
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An Integrated Approach to Ensure the Viral Safety of BiotherapeuticsTesting product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.
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Continuous Processing for the Production of BiopharmaceuticalsThe authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.
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Continuous Processing for the Production of BiopharmaceuticalsThe authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.
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A Coiled Flow Inversion Reactor Enables Continuous ProcessingA novel coiled flow inversion reactor (CFIR) improves process productivity and performance.
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Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor ProcessThe authors present a case study identifying a contaminant.
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Efficient Multiproduct Process Development Case StudyAchieving multiproduct development within shortened timelines.
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Designing a Biomanufacturing Facility Incorporating Single-Use TechnologiesAsking the right questions is crucial to establishing a biopharmaceutical facility design.
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Designing a Control Strategy for Facilities with Single-Use SystemsEarly control architecture decisions can impact a facility’s long-term growth, flexibility, and efficiency.
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Qualification and Validation of Single-Use Shipping SystemsThe authors provide their perspectives on shipping validation.
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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
