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Overcoming Low Endotoxin RecoveryUnderstanding of endotoxin assays and a range of detection technologies are essential for effective testing.
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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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Balancing Protocols for LeachablesWhile the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
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CDMOs Driving Emerging Bio/Pharma SuccessCDMOs can claim credit for the robust growth of emerging bio/pharma financings.
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Playing the Waiting Game with GMP Guideline RevisionsDelays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
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FDA Inspections Face OverhaulThe agency will be reorganizing field force and compliance functions.
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Trump’s Revenge on PharmaThe Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.
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Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable ProcessIn this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
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Point-of-Use Leak Testing of Single-Use Bag AssembliesThe authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Point-of-Use Leak Testing of Single-Use Bag AssembliesThe authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Developments in Aseptic ProcessingCompliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
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Taking a Closer Look at Lipid Nanoparticle CharacterizationAn orthogonal approach to lipid nanoparticle analysis is recommended to optimize drug development success.
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Public–Private Partnerships: Life-Saving Mechanisms of ActionManaging partnerships for the greater good.
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Kinetic and Structural Differentiation of Trypsin from Different OriginsThis study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
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Kinetic and Structural Differentiation of Trypsin from Different OriginsThis study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
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Kinetic and Structural Differentiation of Trypsin from Different OriginsThis study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
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Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
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Cost Considerations Drive Lean Technology in Biopharmaceutical ManufacturingManufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
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Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity TestingThe authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes.
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O2 Measurement GuideGet a better understanding of dissolved oxygen (DO) measurement in Hamilton's comprehensive O2 Measurement Guide. This 72-page booklet is intended for anyone with an interest in DO sensor technology or anyone who needs to implement DO sensors in controlled environments such as laboratories and industrial plants.
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Quality Metrics and CMO AgreementFDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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The Powerful Lesson of the GSK–Whistleblower CaseThose at the top must walk the walk of uncompromising commitment to compliance
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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CDMOs: New Administration, New FrontierDespite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb SolutionThe objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
