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Are You Ready For USP ?Download this application note to learn about hazardous drugs basics - listing through storage, engineering controls and training programs, and why you shouldn’t wait, regardless of initial enforcement for your facility.
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High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal AntibodiesThese new analytical methods can reduce analysis and product development time.
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Leveraging Computational Models of Glycosylation for Biopharma QAClose collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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Cleaning Chromatography Resin Residues from SurfacesLaboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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The Role of Analytical Science in the Debate over BiosimilarsBoth innovator and generics companies are using analytics to support comparability arguments.
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Next Generation Peptide Mapping with Ultra Performance Liquid ChromatographyUltra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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Points to Consider for Continuous Downstream BioprocessingIt is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.
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Complex and Customized: Manufacturing New Molecular FormatsIncreasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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The State of the Used-Equipment MarketToday, there is a global adoption of buying and selling used equipment. This article reviews what organizations should look for when considering the purchase of used equipment.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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Antibody Purification Process Development and ManufacturingDownstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Plants As an Innovative and Accelerated Vaccine-Manufacturing SolutionA plant-based expression system could provide greater speed and capacity at a comparatively low cost.
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Bioengineered Protein A Polymer Beads for High-Affinity Antibody PurificationThe authors discuss an alternative to traditional Protein A resins.
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Outsourcing Lean Quality ManufacturingRapid microbial screening provided by contract laboratories can save companies time and money.
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New Strategies for Managing Single-Use ComponentsDual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.
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New Strategies for Managing Single-Use ComponentsDual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.
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Automated Concentration and Diafiltration of Multiple siRNA SamplesProject: transfer a manual concentration/diafiltration process for siRNA production.
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Extractables and Leachables: Determining Risk in Single-Use SystemsAs SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
