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Latest:
Using TEM-Based Image Analysis to Validate the Presence of HA Spikes on Influenza VLPsThe authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.
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Using TEM-Based Image Analysis to Validate the Presence of HA Spikes on Influenza VLPsThe authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.
Latest:
Using TEM-Based Image Analysis to Validate the Presence of HA Spikes on Influenza VLPsThe authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.
Latest:
Using TEM-Based Image Analysis to Validate the Presence of HA Spikes on Influenza VLPsThe authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.
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INTERPHEX 2024: Single-Use Technologies Reinforce Fluid-Handling WorkflowsBioPharm International® sat down with Nicole Hunter, Watson-Marlow Fluid Technology Solutions’ head of Global WMArchitect at INTERPHEX 2024, to discuss the impact of single-use technologies on fluid-handling workflows in bioprocessing.
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Review by Exception: Connecting the Dots for Faster Batch ReleaseIn batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.
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Challenging Microbial Sanitization of a Liquid Chromatography SystemTo ensure that no contaminating or hazardous residual components remain after protein purification during biologic development, additional sanitization steps may be required for the instrumentation utilized during these processes.
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Building Strategic Relationships with CROsHow to adopt win-win strategies and understand quality agreements for complying with cGMP when building strategic relationships with pharmaceutical contract research organizations.
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The Evolving Role of Starting Materials in Cell and Gene TherapyAccelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.
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The Evolving Role of Starting Materials in Cell and Gene TherapyAccelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.
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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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Lessons from FDA 483s and cGMP Inspection DataProduction and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.
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Assessing Manufacturing Process RobustnessA structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
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Revolutionary Sample Preservation for DNA/RNA AnalysisThe Synergy Tube is a BCT specifically designed to optimize nucleic acid recovery and cancer tumor cells (CTC) from the point of blood draw. The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.
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Revolutionary Sample Preservation for DNA/RNA AnalysisThe Synergy Tube is a BCT specifically designed to optimize nucleic acid recovery and cancer tumor cells (CTC) from the point of blood draw. The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.
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Comparing Fed-Batch Cell Culture Performances of Stainless Steel and Disposable BioreactorsA case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.
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Therapeutic Potential of Green, Synthesized Gold NanoparticlesThis study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.
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Therapeutic Potential of Green, Synthesized Gold NanoparticlesThis study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.
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How Digital Mass Flow Controllers Improve Bioprocessing ResultsThis paper describes the inner workings of digital mass flow controllers to gather, generate, and communicate process data. Utilize this data to improve process control, system uptime, diagnostics, preventive maintenance and yields.
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Optimizing Oligonucleotide AnalysisDue to their ability to tackle targets that were considered undruggable, oligonucleotides represent a key cornerstone of the future of personalized medicine. This infographic presents the different types of therapeutic oligonucleotides and highlights some innovative solutions for their analysis.
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The Status of the DNA Vaccine FieldPlasmid DNA-encoding proteins offer many advantages, which are now being used in clinical trials.
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Digitalization: A CDMO’s PerspectiveCDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.
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How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein CharacterizationComplex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
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Using the “Cubic Effect” to Drive Cell and Gene Therapy CommercializationContract partners must help innovator biotechs consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.
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In-Depth Validation of Closed-Vial TechnologyThe authors describe a validation master plan for closed-vial filling technology.
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Increasing Efficiency in Protein and Cell Production by Combining Single-Use Bioreactor Technology and PerfusionAn off-the-shelf, single-use perfusion system.
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Implications of Trace Levels of Redox-Active Metals in Drug-Product FormulationThe presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
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Successful Wetting for Filter Integrity Testing in Volume-Restricted SystemsPall’s application note offers clear guidance for the successful wetting of filters in challenging situations where low volumes of wetting fluid must be used, such as filters on single-use systems.
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A look under the hood of LunaticLunatic pushes the rock-solid quantification technique of UV/Vis spectrophotometry to the next level of accuracy and throughput with state-of-the-art optics, precision microfluidics, honed signal processing, and purpose-built applications.
