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Increasing Vial-to-Vial Homogeneity: An Analysis of Using Veriseq Nucleation on Production-Scale Freeze DryersThis report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.
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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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Performing a Protein Purity Analysis Comparability StudyA well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.
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Stress and Protein Instability During Formulation and Fill/Finish ProcessesThis article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.
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Going from Fed-Batch to PerfusionPerfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.
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Characterization of TrypZean: a Plant-Based Alternative to Bovine-Derived Trypsin (Peer-Reviewed)An in-depth characterization of maize-derived trypsin revealed an unusual nonconsensus N-linked glycosylation.
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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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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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Supply-Chain Analysis: Solving the FutureSupply-chain analytics can lead to increased profitability.
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The Immune Context in Microbiological TestingThe control of biologics microbiological impurities, contaminants, and mimetics is evolving.
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Safe Freeze–Thaw of Protein Drug Products: A QbD ApproachApply a DoE strategy to test several formulations in parallel.
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Recovering Patent Life with Patent Term ExtensionThe little-known exception to the patent term extension law is potentially valuable but easy to miss.
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Recovering Patent Life with Patent Term ExtensionThe little-known exception to the patent term extension law is potentially valuable but easy to miss.
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Crowdfunding Biopharmaceutical InnovationCaution should be taken when planning to crowdfund a biopharmaceutical startup.
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Seeking Accelerated Biosimilar CharacterizationThe authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
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Using the Purity Quotient Difference to Assess Protein PurificationAn automated analytical method determines the purity of chromogenic, fluorescently tagged proteins or metal-bound proteins.
