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Spectroscopy Facilitates Lean AnalysisSpectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
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Spectroscopy Facilitates Lean AnalysisSpectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
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Fundamentals of GMP Warehouse DesignStorage and retrieval methods and the unique requirements found in building codes are crucial considerations.
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A User-Friendly Approach to Developing an Extended-Release ProductThe challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.
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LIGHTHOUSE Instruments Launches New Products for Robust Headspace Data Generation at the CPHI in BarcelonaLIGHTHOUSE Instruments introduces new technology for robust headspace data generation and areas of application.
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Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical ManufactureTech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.
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Has Outsourcing Derailed PAT and QbD?Quality management requires more effort in a complex supply chain.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Analysis of Sub-Visible ParticlesNovel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
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Accelerating Biopharma Development and Manufacturing through CDMOs and CGTWebinar Date/Time: Thu, Jul 20, 2023 11:00 AM EDT
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CMOs Leading the Way on Single-Use Systems AdoptionSingle-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
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Characterizing Biotherapeutics and Determining Biosimilar ComparabilityThe ability of SPR-based analysis to estimate association and dissociation rate constants is a major advantage over the traditional steady-state analysis of biomolecules.
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Pharmaceutical Compounding Calculations, Part Two–Bulk DrugsBulk drug calculations for different types of active moieties and drugs require different calculations and labeling.
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Utilizing Spectral Analysis in HPLC Diode Array to Discover ImpuritiesInvestigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.
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Quantification and Characterization of Polysorbate-80 in Protein FormulationsHPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.
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FDA Modernizes Controlled Correspondence Interactions with Pharma IndustryAs part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
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FDA Modernizes Controlled Correspondence Interactions with Pharma IndustryAs part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
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Direct Compression Versus GranulationCompressed tablets are the most widely used solid dosage form so they must satisfy a number of physical requirements in terms of hardness, disintegration ability, friability and uniformity.
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Improving Process Mass Intensity for Bio/Pharmaceutical ProductionProcess optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Assuring the Safe Handling of Potent APIs, Intermediates, and Solid-Dosage DrugsContainment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.
