Authors
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Perspectives in MicroRNA TherapeuticsThe authors provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
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Implementing Single-Use Technology in Tangential Flow Filtration Systems in Clinical ManufacturingA case study evaluates the performance, control of operations, productivity, and cost savings of a single-use system.
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Perception and Costs of Biotech InnovationThe lower price of biosimilars will increase patient access to medicines and spur innovation.
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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The Quality Product Steward Model: The Genentech ApproachA successful QPS acts as a single point of contact for consistent product quality oversight.
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Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
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Benefits of a Revised Approach to Anion Exchange Flow-Through Polish ChromatographyA high-performance anion exchange resin performs well compared with membranes. In addition, the resin offers greater flexibility and cost savings.
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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Addressing the Challenges in Downstream Processing Today and TomorrowNewer classes of biotherapies will require innovations in processing technology.
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Technologies for Downstream ProcessingThe author describes recent developments to help overcome the downstream-processing bottleneck.
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic ProductsEstablishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
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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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Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
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Adopting the Product Lifecycle ApproachThe author presents opportunities and challenges in implementing the product lifecycle approach.
