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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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Assessing Data Integrity Risks in an R&D EnvironmentA data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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Converting Injectable Therapies to Combination Drug-Device ProductsThe author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.
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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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A Catalyst for Environmental ConsciousnessA recent book shows the links between synthesis, catalysis, and environmental protection.
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The Ideal PharmacopeiaThis position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.
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Accelerating Biopharma Development and Manufacturing through CDMOs and CGTWebinar Date/Time: Thu, Jul 20, 2023 11:00 AM EDT
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Selecting a freeze dryerThe most important consideration when choosing a freeze dryer is to ensure the system is fit for both today's applications and future needs.
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Key Considerations When Repositioning a Known Drug for Inhalation TherapyCreating an inhaled formulation is one way in which improved efficacy or added value can be achieved in projects to repurpose or reposition existing drugs.
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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.
