Authors
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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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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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Advanced Liquid Particle Counters to Measure Aggregated ProteinsLiquid particle counters are ideal for protein aggregation studies.
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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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The Role of Quality Standards for Biomanufacturing Raw MaterialsManaging and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
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Re-use of Protein A Resin: Fouling and EconomicsLarge-scale implementation of Protein A chromatography offers several challenges.
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Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
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Re-use of Protein A Resin: Fouling and EconomicsLarge-scale implementation of Protein A chromatography offers several challenges.
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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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Creating a Holistic Procurement SystemThe procurement organization rethinks sourcing for maximum efficiency and results.
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Preclinical Evaluation of Product Related Impurities and VariantsThe approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
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N-Glycan Composition Profiling for Quality Testing of BiotherapeuticsAdvances in glycan analysis are enhancing biologics development and quality control processes.
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Knowledge Management ImplementationThe authors discuss the technology and guidance required to achieve good KM in a biopharmaceutical company.
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A Biopharmaceutical Industry Perspective on Single-Use Sensors for Biological Process ApplicationsThis article presents first-hand perspectives from industry users to suppliers of single-use sensors.
