Authors
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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.
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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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Adopting the Product Lifecycle ApproachThe author presents opportunities and challenges in implementing the product lifecycle approach.
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Quality by Design and Extractable and Leachable TestingThe author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
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Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
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Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
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Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
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Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
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Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
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Reinventing the Cold Chain in a High-Stakes MarketMarket changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.
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Reinventing the Cold Chain in a High-Stakes MarketMarket changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.
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Dealing with Pharmaceutical Supply-Chain ComplexitiesPlanning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.
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FDA Publishes Draft Guidance on Tablet ScoringFDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets. The document also describes nomenclature and labeling, and is intended to facilitate the evaluation of these products.
