Pharmaceutical Technology
October 03, 2020
Cover Story
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More complex and challenging compounds require a more tailored approach to formulation strategies.
October 03, 2020
Peer-Reviewed Research
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This 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.
October 03, 2020
Development
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Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.
October 03, 2020
Development
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Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.
October 03, 2020
Manufacturing
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Research is striving to make pharmaceutical processes more scalable by making them simpler and easier to replicate and control. Advances include 3D printing, as well as miniaturized and continuous processes, all of which are being aided by improved automation and analytics.
October 03, 2020
Manufacturing
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The manufacture of gene therapy vectors is shifting to more modern technologies.
October 03, 2020
Manufacturing
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Industry experts discuss challenges and best practices for scaling up manufacturing under a short deadline.
October 02, 2020
Quality/Regulations
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The case for migrating from a paper-based quality management system to a digital platform is presented.
October 02, 2020
Quality/Regulations
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A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.
October 02, 2020
Operations
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Facility and equipment design are important, but the team and its experience matter most.
October 02, 2020
Operations
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End-to-end traceability can provide more value than just securing drug product safety.
October 02, 2020
Outsourcing
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Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
October 02, 2020
Regulatory Watch
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Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
October 02, 2020
Regulatory Watch
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Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
October 02, 2020
From The Editor
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Misleading messages contribute to eroding trust in public health agencies.
October 02, 2020
From The Editor
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European pharma companies may have a vested interest in the outcome of the US elections.
October 02, 2020
Ask the Expert
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The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.
October 02, 2020
Product Spotlight
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Cytiva announced that it is launching the Xcellerex Automated Perfusion System (APS), a device aimed at simplifying processes and reducing risks when intensifying upstream operations.
October 02, 2020
Product Spotlight
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The ROSS VMC-1000 VersaMix is a 1000-gallon triple-shaft mixer available on a pivot-design single-post hydraulic lift.
October 02, 2020
Product Spotlight
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Beckman Coulter Life Sciences announced that its MET ONE 3400+ portable air particle counter is now available for cleanroom compliance.
October 02, 2020
Product Spotlight
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The Spectrum Compact CE System from Promega is a benchtop capillary electrophoresis (CE) instrument that allows users to perform sequencing and fragment analysis at the bench in laboratories of all sizes.