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Using Robotics in the Aseptic Manufacturing Facility of the FutureSeveral steps need be taken to achieve lights-out, fully automated operations.
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SMEDDS incorporated polymer matrix: A floating dosage form solution for drugs with poor gastric solubilityA new kind of gastro-retentive dosage form for drugs with poor aqueous solubility was developed and evaluated, with the aim of achieving gastro-retention.
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Ensuring Quality & Compliance in Pharmaceutical Raw Materials: gChem’s Approach to ICH Q7 and Supply Chain IntegrityIn this interview, Sandra Reid of gChem explains how PROCIPIENT®, its USP-grade DMSO, is uniquely manufactured under cGMP and ICH Q7 guidelines to ensure compliance, consistency, and quality across global pharmaceutical markets.
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Inside USP: USP Metals Testing: A Workshop ReportAttendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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Navigating the Preclinical CRO Outsourcing ProcessThe need for preclinical testing expertise is growing as molecular complexity increases.
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Enhancing Patient-Centric Care Through Oral Liquid Drug Delivery FormulationsThe growing demand for liquid medicines is increasingly driven by the unique needs of several distinct patient groups, improving compliance in these demographics through flexible, palatable dosing options.
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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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Challenges in the Secondary Manufacture of Encapsulated High-Potency DrugsLiquid and semisolid encapsulation using two-piece hard capsules is an ideal drug delivery approach for highly potent compounds and poorly water-soluble drugs. The authors detail the factors to reduce risk when designing and operating a facility for secondary manufacturing of highly potent drugs.
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Improving Operational Efficiency with Digital IntelligenceLeveraging predictive data to drive value and maximize manufacturing uptime.
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A SWOT Analysis Of The Biosimilars MarketA Strengths, Weaknesses, Opportunities and Threats analysis of the biosimilars market is given.
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New Possibilities in Pharmaceutical Processing with RAM TechnologyWebinar Date/Time: Wed, Oct 8, 2025 11:00 AM EDT
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Assessing Legacy Drug QualityA data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Finding the Right System for Moving Pharmaceutical MachineryIt’s crucial to consider the optimal handling systems for cleanroom and other lab environments.
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Nitrosamine Impurities in Medicinal ProductsIndustry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
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Inside USP: Metrology and USP DissolutionThe United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
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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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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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Overcoming manufacturing and financial challenges of personalized cell therapiesPerson-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.
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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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Exploring Multimodal Biomanufacturing and Its DriversA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Assessing the Success of CRISPR Gene Therapies Using ddPCRUsing more exacting analytical tools can give a clearer assessment of gene-editing outcomes.
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An Intelligent Drug Development ParadigmAn intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
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Fabrication Modulation of Zein-based Fibers for Oral Delivery of HydrochlorothiazideThis study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.
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Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream BioprocessingThe need for real-time monitoring and control has spurred the development of new analytical tools.
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The COVID-19 Pandemic and Its Positive Impact on RNA Drug DevelopmentThe COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.
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The Age of Big Q: A Full Organization Obsession with Customer SuccessQuality is one of the most important components of products in pharmaceuticals. Traditionally, the onus was on the manufacturing function to deliver quality. But what if every single member of the organization was completely focused on customer needs? Big Q, or Quality culture, ensures that quality is up to everyone. DuPont expert will discuss more about how its excipient platform is taking customer cues to implement this total quality focus.
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Design of an Aseptic Process SimulationThe authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
