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Minimizing Contamination During BioPharm R&DThe right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.
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Good Automation Practices in the LaboratoryLaboratory automation can reduce the need for in-lab user presence but requires efficient and dependable user-system interface.
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Good Automation Practices in the LaboratoryLaboratory automation can reduce the need for in-lab user presence but requires efficient and dependable user-system interface.
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What’s Next in Air Transportation for Clinical Trial LogisticsThe future will bring changes for temperature-controlled container rental companies.
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Good Automation Practices in the LaboratoryLaboratory automation can reduce the need for in-lab user presence but requires efficient and dependable user-system interface.
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Testing for Nitrosamines in Pharmaceutical DrugsRecent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.
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Why Do Disinfectant Residues Matter?Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.
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Refining Microbiological Control for Non-Sterile ProductsSubsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.
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Advanced Analytics Delivers Continuous Manufacturing InnovationAdvanced analytics streamlines continuous manufacturing by providing improved insights to data.
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Executive Summary: Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Inhaled Product Design and DevelopmentThe regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.
