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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Special Packaging Delivers Inhaled Insulin Globally, 194 million people suffer from diabetes and this number is rising rapidly. For these patients, a regular regimen of pills or injectable insulin is necessary to control blood-glucose levels. Bringing Exubera, the world's first inhaled insulin, to market requires extensive collaboration by Pfizer, Nektar Therapeutics, West Pharmaceutical Services Tech Group, and Bespak.
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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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Spotlight on 4th Generation Electronic Document Management (EDM) Systems To successfully achieve the vision and effectively manage EDM projects, first categorize the current state of your EDM system, then build a road map with manageable phases to reach the desired end state. The goal of this article is to provide: (1) real-world examples of valuing EDM projects; (2) methods for categorizing a required solution; and (3) useful guidelines and rules of thumb for building a road map after the solution has been categorized.
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