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In a Digital Gold Rush, Data Integrity is PricelessData integrity is crucial in unlocking novel data-based insights.
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Selecting a CMO Partner for Sterile Injectable Manufacturing (Nov 2023)Vetting a CMO for sterile injectable fill finish means more than capacity and equipment. This white paper from Jubilant HollisterStier discusses the range of factors to consider when outsourcing manufacturing for aseptically filled and terminally sterilized products.
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Reducing Risk With Innovative Surface Cleaning SystemsSean Imlay, FG Clean Wipes, highlights the Saturix® Surface Cleaning System during INTERPHEX 2022. Watch this video to learn more about:
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Solving the Insoluble: Webinar on the Science and Application of the Dispersome® TechnologyWebinar Date/Time: Tue, Nov 12, 2024 9:00 AM EST
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Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?Advanced manufacturing technologies are available, but challenges need to be addressed.
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Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime ProxetilThis study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
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Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access ProgramsChallenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.
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The Field Guide to Pharmaceutical Powder Characterization (July 2023)If you want to learn more about the physical characterization of your pharmaceutical powders, download this free e-book. You will find real measurement data that has been collected from a range of characterization methods, including particle, surface area and pore size analysis, powder rheology, and X-ray diffraction. Deepening your understanding of bulk particle properties is just the first step to get more predictable formulations and optimized processes.
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3D Screen Printing: Enabling A New Generation of Complex Formulations3D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.
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Navigating an Uncertain Regulatory Environment for mRNA-based ProductsRegulations for mRNA products are evolving as the market for mRNA expands.
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Raman Detects Pharma Processing FingerprintsRaman spectroscopy delivers real time, non-destructive process insights for critical process parameters to monitor pharmaceutical manufacturing.
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Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Effective and Efficient Weighing of Potent CompoundsThe advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
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Manufacturing Considerations for Sourcing GMP Fermentation ServicesThe authors describe the critical aspects of an ideal fermentation services provider.
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The Lighthouse Effect: Using Technology to Improve Life Sciences ManufacturingLighthouse manufacturing techniques utilize technology and automation to streamline production.
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Changing the Dynamic of CROsThrough its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.
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Industrial Applications of Whole-Cell BiocatalysisRecombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
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Legal and Regulatory Perspectives on 3D Printing: Drug Compounding ApplicationsThis paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.
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Dielectric Spectroscopy: Choosing the Right ApproachThis tutorial paper is meant to aid in dielectric-sensor selection
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Thermal fingerprinting: a way to optimize lyophilizationFreeze drying is widely used in pharmaceuticals to improve the long-term storage stability of labile drugs.
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The current and future market for SNPsSingle nucleotide polymorphisms (SNPs) are responsible for more than 80% of the variations between individuals, and are present throughout most genes and other important sequences in the human body, which makes them ideal for tracking down correlations between genotype and phenotype.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Change management: common failures and a checklist for improvementThough the pharma industry has improved its change management processes, there are still opportunities for improvement.
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Common FDA 483 Observations for Combination ProductsAny improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.
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Development of a Validated Method of Testing for NDMA in RanitidineThis article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
