HealingWell.com 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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Closing Gaps in Quality Control of Electronic Data All potential uses and supporting endeavors of the data must be examined and then defined as a virtual process stream. The implementation of good quality electronic systems is challenging. In most organizations, business processes are entrenched, personnel are overworked, and financial resources are limited. Sometimes these organizations do not understand that aspects of their electronic environment are out of compliance or even worse, may even not realize the need for compliance.
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What it Costs to Operate a Biopharmaceutical Facility Operating costs are the white-hot issue in the boardrooms of life sciences companies and they tend to rule the site selection process. A soft economy, worldwide trade competition, drug cost containment pressures from the US government, and a lean and mean message sent by the venture capital community mean that quantitative factors that focus on the cost of doing business are trumping qualitative lifestyle factors, especially when evaluating sites for a new biopharmaceutical facility.
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Securing Your Company's Manufacturing Data A 2000 cyber crime study revealed that 71 percent of security breaches were caused by people who worked within the company.
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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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