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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FDA Publishes Draft Guidance on Tablet ScoringFDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for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.
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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.
