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Costing Issues in the Production of BiopharmaceuticalsOperational planning and early cost analyses are key to generating optimal, robust, and economical commercial processes.
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Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed)The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.
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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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Single-Use Technology for Syringe FillingA novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.
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Unveiling CQA Insights for mRNA, LNPs, and Viral Vectors by SEC and MALS With Novel 1000 Å Ultrawide Pore Particle ColumnsWebinar Date/Time: Thu, Sep 5, 2024 11:00 AM EDT
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The Case for Pediatric ExclusivityReauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew.
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A Protocol for Trademark ProtectionThe Madrid Protocol offers companies another option for trademark registration on a global scale.
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Mechanistic Modeling of Preparative Ion-Exchange ChromatographyChromatography modeling can enhance bioprocessing efficiencies.
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Strategic Outsourcing in Clinical DevelopmentPartnering with CDMOs can help bridge the innovation gap.
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HIV Drugs Produced from Goats Show PromiseMolecular mimicry is a common, but undesirable, property of disease proteins. Sequence similarities between cancer proteins and self-proteins allow tumor cells to hide, thereby avoiding attack from the immune system. HIV uses the same evasive tactic.
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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?
