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Challenges When Outsourcing Viral Safety ServicesAssessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
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Polypeptide Multilayer Nanofilms in Drug DeliveryInvestigators are exploiting the tremendous structural diversity of polypeptides and their biophysical properties to develop novel drug carriers. Peptide-based materials hold out much promise for tailor-made targeting, penetration, and release of contents in a host of biological microenvironments.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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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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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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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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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.
