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Ensuring mAb Stability Through ModelingEnsuring the stability of biotherapeutics can be achieved through kinetic models that study aggregation and fragmentation.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
Latest:
Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
Latest:
Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
Latest:
Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Advanced Analytical Approaches for Accelerated Development of Gene Therapy ProductsDownload the White Paper and learn how detailed characterization can guide successful development of gene therapy products.
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Raising the Bar on Tablet Manufacturing-- Innovations in Tablet Press Technology -- Containment for Tableting: Best Practices -- Direct Tableting a Mixture of a Powder Matrix and API Loaded Pellets
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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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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 One–Non-Salts, Salts, and Policy-Exception SaltsCalculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.
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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.
