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A conversation with Vanessa Fernandes, Sanofi | The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Seal Replacement As A Cost Avoidance Strategy | Article | Asahi Kasei Bioprocess | Proactive seal replacement in biopharmaceutical manufacturing prevents costly failures and downtime, ensuring product quality and process integrity. |
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| FDA's Regenerative Medicine Advanced Therapy (RMAT) Program | White Paper | By Isaiah Manoogian, Pace Life Sciences | RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review. |
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| Powering The Next Generation Of Drug Delivery Systems | Article | 3P innovation | Discover how extrusion, including aseptic methods, enables advanced drug delivery systems, detailing the critical process controls required for success with complex and novel drug products. |
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| Soluble Versus Insoluble Expression In Microbial Fermentation | Article | By Nikolay Krumov and Jonas Mueller, Lonza | Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges? |
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