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Latest:
QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
Latest:
QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Stability Studies: An Essential Step for Quality Management in Drug DevelopmentSufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
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An Alternative to the USP Disintegration Test for Orally Disintegrating TabletsThe authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
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REACH: has the cloud of confusion cleared?The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.
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Tackling Cybersecurity Challenges in Legacy SystemsOngoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
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Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
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Automated Inspection of Pre-filled Syringes and Biologics During Fill/FinishShifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
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Self-Emulsifying Drug Delivery SystemsThis review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.
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Empowering Pharmaceutical Quality Control Laboratories through Strategic Change ManagementChange management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?
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BioSpectra Announces Launch of New Class 6 Manufacturing SuiteBioSpectra Launches Class 6 Manufacturing Suite for Sterile filtered, GMP bulk Solutions, utilizing sterile, SUT packaging. First product launch: 5M NaCl solution made with WFI and multi-compendial salt.
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Looking Ahead to Factors Shaping Market ActivityDespite the market challenges caused by COVID-19, M&A activity in the life sciences sector is recovering well.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Dose Administration, Compatibility, and Clinical Usability of BiologicsWebinar Date/Time: Mon, Nov 18, 2024 11:00 AM EST
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Navigating the Formality Spectrum in ICH Q9(R1)The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Assessing environmental risk of pharmaceuticalsAn environmental risk assessment (ERA) is now required for all new pharmaceutical product marketing authorisation applications. The author outlines the steps to this procedure.
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How to Evaluate a CDMO’s Commitment to QualityWhat do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?
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Leveraging Cygnus Technologies Quality with Fully Automated CHO HCP Assays on Ella: whitepaper:In this application note, we pair Simple Plex Assays on Ella with Cygnus 3G CHO antibodies for superior sensitivity and data reproducibility throughout bioproduction.
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Data Matrix Barcodes: Print Quality and Popularity On The UpThe 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.
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iMRI-Guided Gene Therapy and Drug Delivery for CNS DisordersLeveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.
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Revolutionizing Biomanufacturing: The Digitalization AdvantageDigital transformation allows for smarter and connected biomanufacturing operations.
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Low Temperature Spray DryersExperts in solid dosage technology, offering electrostatic spray dryers, fluid bed systems, and other process solutions used daily to help the pharmaceutical, nutraceutical, food, fine chemical, and biopharmaceutical industries.
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ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable FacilitiesThis paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
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Handling HPAPIsThe manufacture of high potency active pharmaceutical ingredients (HPAPIs) is on the rise with R&D projects showing a continuing interest in these products.
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Phase-appropriate Analytical MethodologyA phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
