Global RPH Drug Development and Manufacturing Center - Industry reports, technical articles and news covering the drug development and manufacturing sector. This includes professional practice news and care reports regarding legislative and regulatory matters, research development, scale-up and manufacturing. Topics cover the entire drug production process, from raw materials and excipients through drug discovery and delivery to packaging and supply chain management

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Drug Development and Manufacturing

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Improving the Physical and Chemical Properties of Ibuprofen The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.
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Rapid Microbiological Methods and the PAT Initiative PAT can be defined as a collection of real-time data in-line to make decisions about product quality early in the production process.
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Small-scale Biomanufacturing Benefits from Disposable Bioreactors The cell density achieved in a CELLine bioreactor is typically 1 to 2 orders of magnitude higher than in a conventional culture vessel.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case Report Cell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum Many industry professionals know that analytical testing for biopharmaceuticals for all raw materials, production in-process stages, and final containers must be validated, and they generally understand how this can be achieved. However, how exactly are analytical test method performance and process robustness related and how do they depend on each other?
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