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Outsourcing of Nonclinical Studies for Drug Development: Tips and TrendsLearning to think with the end in mind will help clients and their selected CRO to design and conduct the right studies.
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Supplier-Change Management for Drug-Product ManufacturersAn effective supplier-initiated change management process is discussed.
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Logistics of Cleaning ValidationA guide for improving the planning and preparation of future validation work.
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Novel Hydrophobic Interaction Chromatography Resins for Next Generation Biotherapeutic ChallengesDesigned to solve complex downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins (POROS HIC) has been developed that cover a wide range of hydrophobicity.
Latest:
Novel Hydrophobic Interaction Chromatography Resins for Next Generation Biotherapeutic ChallengesDesigned to solve complex downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins (POROS HIC) has been developed that cover a wide range of hydrophobicity.
Latest:
Novel Hydrophobic Interaction Chromatography Resins for Next Generation Biotherapeutic ChallengesDesigned to solve complex downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins (POROS HIC) has been developed that cover a wide range of hydrophobicity.
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Angiopoietins: Novel Targets for Anti-angiogenesis TherapyThe authors review the angiopoietin pathway as an alternative for safer and more efficacious anti-angiogenic therapeutics.
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Applying Lessons Learned from the Semiconductor IndustryApplying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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Applying Lessons Learned from the Semiconductor IndustryApplying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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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.
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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.
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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.
