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Hard Capsules as a Flexible Dosage FormInnovations in hard-capsule technology enhance the flexibility that hard capsules can provide for dosage forms.
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Process Development Best Practices for Topical Drug ProductsUsing a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
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Process Development Best Practices for Topical Drug ProductsUsing a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
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Natural Superpowers? Supernatural Wide pH-Range!SCHOTTs latest vial innovation, is the only barrier coating for high pH fillings with hydrophobic surface combining all advantages of the Type I middle borosilicate glass container and the well-known 1-layer PICVD coating of SCHOTT.
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AAPS Traces the Path to ICH M10Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
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Standards-Setting Activities on ImpuritiesUSP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
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Improvement of Structural Profiling of N-glycans in BiologicsA suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.
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Improvement of Structural Profiling of N-glycans in BiologicsA suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.
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Improvement of Structural Profiling of N-glycans in BiologicsA suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.
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Improvement of Structural Profiling of N-glycans in BiologicsA suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Using Nondestructive in-situ Measurements to Ensure Lyophilized Product StabilityNon-destructive surface area measurement can improve stability testing.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Perspectives in MicroRNA TherapeuticsThe authors provide further insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
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Transformations in Drug Development for Cell and Gene TherapiesAs a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
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Strategies for Managing the Impact of Brexit for US Biotech CompaniesThis article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.
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Mucoadhesion GuideLooking to improve drug product effectiveness and differentiate? Mucoadhesion – the ability of a formulation to adhere to a mucous membrane – is an attractive option for those keen to ensure their products stand out in a crowded market.
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Improving Your mAb Purification• WorkBeads™ 40 TREN is an excellent tool as a guard column upstream protein A resins • WorkBeads 40 TREN removes ~99% of HCD, reduces HCP ~3-fold & removes >93% of endotoxins WorkBeads affimAb in a single step gives a 10-fold more pure mAb eluate than MaSelect SuRe™
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Protecting Drug SafetyIn the past 10 years, safety issues have become increasingly important in pharmaceutical packaging, from needle sticking safety to counterfeit protection.
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Accelerating Biosimilar AnalysisMass spectrometry should be utilized effectively to optimize biosimilar analysis, which can reduce development time and cost.
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Challenges In The Changing Outsourcing LandscapeOriol Prat, Marketing Manager, and Marga Viñes Senior Product Manager, from Grifols give us a quick rundown of how business is changing and what challenges the company faces.
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Enterprise Resource Planning Systems Provide Supply Chain TraceabilityAn ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.
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Industry Outlook 2025: The Future of Technology in the Biopharma IndustryThe PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.
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Design Space Characterization and Risk Assessment Through Mechanistic ModelingMechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.
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Design Space Characterization and Risk Assessment Through Mechanistic ModelingMechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making is compared with a QbD approach.
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Determining Water Content with a Novel Karl Fischer Titration ApproachA new approach to testing water content in biologics is needed that will give a more accurate determination of actual water content in the biologic.
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The Impact of Vortexing on the Particle-Size Distribution of PharmaceuticalsIf a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution.
