Authors
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Understanding Lyophilization Formulation DevelopmentThe author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.
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Particle size analysisAn expert on diffraction systems offers insight on particle size specifications and analysis.
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Optimizing Cross-Organizational Team Performance and ManagementTreating a cross-organizational team as a full-fledged partnership helps complete a project on time and on budget.
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Cyclodextrins as Sustained-Release CarriersCyclodextrins can improve the physiochemical properties of various sustained-release formulations.
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Field-Flow Fractionation With Multiangle Light ScatteringAbsolute macromolecular characterization is a separation technique that combines AF-FFF with MALS instruments...
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Protecting Intellectual Property Prior to CommercializationThis article looks at the different approaches to patenting in Europe and the US...
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Inside the Outsourcing Relationship: Real Life Lessons from Contract Manufacturing Services Partners… the real glue that holds the partnership - and project - together, even more so than a formal contract or quality agreement, is the ability to communicate regularly and honestly with each other.
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The Relationship between Saturated Hydrogen Peroxide, Water Vapour and TemperatureHydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.
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Patients Wade into the European Pricing DebateAn important third party is struggling to make its voice heard in European pharma discussions.
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Milling Made Easy: Nanoindentation as a Predictor of Bulk PropertiesSize reduction of materials through comminution is employed in many industries, including agrochemicals, minerals, ceramics and pharmaceuticals. The reasons for particle size reduction depend on the industry in question. Within the pharmaceutical industry, a large percentage of products are formed from powders and undergo processing to improve dosage form properties. Particle size reduction prior to compacting to tablets can aid with dissolution and homogeneity. Such processing of powders is, in part, dependent on their mechanical properties and balancing these properties is crucial in achieving desired manufacturing performance. Generally, pilot-scale milling trials are run to determine the most effective and efficient mill and operating conditions for each material. These trials, however, require relatively large quantities of material as well as time, and are normally run in early development when sufficient material becomes available. Hence, it would be highly beneficial to identify a physical property..
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Common Cleanroom MythsMyths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.
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Making A Mark In Emerging MarketsMarc Prieur of Aptar pharma describes success stories in emerging markets.
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Technical Note: The Effect of Alcoholic Beverages on Sustained ReleaseThe authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.
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Developing and Sustaining a Quality CultureEmployee training-at all levels-is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.
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Optical Character Recognition and Code VerificationInspection systems play a big part in ensuring product quality.
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Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze DryingA new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
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A Practical Approach of Implementing GMP for ExcipientsUsing a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
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Research Spend On Cancer Doubles Within A DecadePartners of the UK's National Cancer Research institute (NCRI) have nearly doubled their spend on cancer research in the last ten years.
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Key Considerations When Choosing Your Cleanroom DoorOne of the biggest challenges in designing cleanroom doors for the pharmaceutical industry is in creating a sturdy door with a high hygienic performance that is light and easy to clean.
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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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De-activating the Ticking Bomb of Brain Diseases with NanomedicinesNanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
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Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
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Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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Assessing and Improving the Palatability of PharmaceuticalsTaste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.
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Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
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Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
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Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
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Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
