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Latest:
Host-Cell Protein Measurement and ControlThis article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.
Latest:
Host-Cell Protein Measurement and ControlThis article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.
Latest:
Host-Cell Protein Measurement and ControlThis article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.
Latest:
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.
