Authors
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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: European Political Impacts on the Supply ChainThe PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.
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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.
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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.
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Managing Hazardous Waste from Pharma ProcessesPharmaceutical manufacturers must stay compliant with changing regulations for hazardous waste disposal.
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Best Practices in Analytical Method Development and TestingThis article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
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Microbiology & toxicology testing services for the medical device and pharmaceutical industries.Wickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries with over 50 years of experience in contract testing, research and consultancy.
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Driving Data Quality and Ensuring Compliance Using Modern CDS SolutionsThe most safe and effective therapies demand the highest data quality.
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Improving Production: How IT, OT, and Quality Can CollaborateTo improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.
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Improving Production: How IT, OT, and Quality Can CollaborateTo improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.
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Biosimilar Analysis: A Varied ApproachUsing several techniques at different conditions during biosimilar analysis testing offers an improved understanding of a dynamic situation.
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Unprocessed Bulk Testing for BiopharmaceuticalsUnprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
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Simulating Reality in Mock InspectionsMock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
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Quality's Unsung Hero: The GxP Training MatrixCompanies can benefit from developing a single programmatic approach to a GxP training matrix.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
