Authors
Latest:
Evaluating Surface Cleanliness Using a Risk-Based ApproachRinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
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Navigating the Biosimilars MarketThe market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.
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Implementing Single-Use Technology in Tangential Flow Filtration Systems in Clinical ManufacturingA case study evaluates the performance, control of operations, productivity, and cost savings of a single-use system.
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The Use of the ATF System to Culture Chinese Hamster Ovary Cells in a Concentrated Fed-Batch SystemCell concentrations and resulting protein concentrations are higher in a concentrated fed-batch process than in a standard fed-batch culture system.
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Evolution of the Monoclonal Antibody Purification PlatformThe authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
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Customer Relationship Management in Contract ManufacturingThe authors examine the selection process of the contract manufacturing–pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.
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Customer Relationship Management in Contract ManufacturingThe authors examine the selection process of the contract manufacturing–pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.
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Gearing Up for BiosimilarsContract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.
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Operations and Quality Oversight of CMOsEffective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.
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Troubleshooting Lab Operations: Be Proactive, Not ReactiveThis article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Update on Continuous Bioprocessing: From the Industry’s Perception to RealityAlthough widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.
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N-Glycan Analysis of Biotherapeutic ProteinsThis article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
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Storing and Shipping Frozen APIs in Single-Use ContainersAs more companies decouple drug substance from finished drug manufacturing operations, an integrated approach can ensure safe, reliable logistics for frozen storage and shipping.
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Storing and Shipping Frozen APIs in Single-Use ContainersAs more companies decouple drug substance from finished drug manufacturing operations, an integrated approach can ensure safe, reliable logistics for frozen storage and shipping.
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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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A Novel Metric for Continuous Improvement During Stage ThreeHow statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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A Novel Metric for Continuous Improvement During Stage ThreeHow statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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Drug Spending Not Driving Rising Healthcare CostsNew reports indicate that drug prices are slowing compared to other healthcare costs.
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A Novel Metric for Continuous Improvement During Stage ThreeHow statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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Product Characterization: Reveal Your Molecule Earlier, Faster, and with Accuracy* Early investment and product characterization is key for biologics * What stages are best for product characterization? * Outsourced product characterization services
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Harvest of Human Mesenchymal Stem Cells from MicrocarriersTraditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
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Harvest of Human Mesenchymal Stem Cells from MicrocarriersTraditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
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Harvest of Human Mesenchymal Stem Cells from MicrocarriersTraditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
Latest:
Harvest of Human Mesenchymal Stem Cells from MicrocarriersTraditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
