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Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and FiltrationCreation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes - chromatography and filtration.
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Emerging Bioprocessing MethodsNew technology is designed to improve production efficiency by taking advantage of the properties of single-use bags.
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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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Bucking the TrendA perspective on why platform processes are not and should not define the future of bioprocess development efforts. This article is part of a special section on biopharmaceutical trends.
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Oral Delivery and Recombinant Production of Peptide Hormones, Part II: Recombinant Production of Therapeutic PeptidesThis technology includes an efficient and scalable in vitro enzymatic amidation step for peptide hormones.
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Reduce Analytical Testing and Costs Without Compromising ComplianceUnnecessary analytical testing can lead to unnecessary costs.
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Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
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Operational Excellence: More Than Just Process ImprovementBy embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
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Oiling the Engines of InventionBig Pharma execs bring to biotech the knowledge of what it takes to make something a commercial success-not getting to market, but to Phase I.
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New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic FormulationsNew research shows KLEPTOSE® BIOPHARMA as a potential functional alternative to surfactants within biologic formulations, learn more from Roquette’s experts Peter Ferguson and Pen Tao. Live: Tuesday, Oct. 29, 2019 at 9am CDT | 10am EDT | 2pm GMT | 3pm CET On demand available after airing until Oct. 29, 2020 Register free
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Efficient Prion Removal from Gonadotropin Solutions by Nanofiltration MembranesCan a nanofiltration process be leveraged for removal of prions?
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An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental ImpactsAn environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.
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Concentrating Feed—an Applicable Approach to Improve Antibody ProductionDifferent approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.
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A Method for Removal of Endotoxin from Pharmaceutical FormulationThe authors describe a simple method to remove endotoxins from highly viscous formulations.
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Characterization of Biomacromolecules by FPLC-MALS v2The coupling of FPLC to MALS not only detects but also quantitatively determines the absolute molecular weight and size of each species, including the targeted molecules, impurities, and its aggregates.
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Efficient Prion Removal from Gonadotropin Solutions by Nanofiltration MembranesCan a nanofiltration process be leveraged for removal of prions?
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The Economic Challenge of Prescription–Diagnostic CombinationsWith the rise in therapeutics comes more complex partnerships.
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Efficient Prion Removal from Gonadotropin Solutions by Nanofiltration MembranesCan a nanofiltration process be leveraged for removal of prions?
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Biopartnering Down UnderAustralia's pharmaceutical industry as a whole turns over approximately US$10.7 billion a year and spends some US$384 million annually on research and development.
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Gastric-State-Controlled Bioequivalence StudiesEstablishing bioequivalence is difficult for drugs with high inter-subject variability or strong dependence on the physiological state of the gut.
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Advancing Analysis of Covalent High Molecular Weight InsulinLearn about new advancements for achieving increased component resolution, shorter run times and more consistent recoveries of HMWPs with outstanding reproducibility.
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Comparing Protein A Resins for Monoclonal Antibody PurificationA prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
