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FDA Publishes Draft Guidance on Tablet ScoringFDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for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