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Extractables and Leachables

Extractables and leachables are critical considerations in the development and quality control of injectable drug products. Extractables are chemical compounds that can be extracted from packaging materials, container closures, or delivery systems when exposed to solvents under exaggerated conditions (e.g., high temperatures, aggressive solvents). Leachables are chemical compounds that migrate into the drug product under…

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Persist AI and Nivagen to Collaborate on AI-Driven Manufacturing Process for Long-Acting Injectable

The two companies intend to leverage their complementary expertise and technology to bring a novel long acting injectable and drug product manufacturing platform to market. Persist AI and Nivagen have announced a collaboration to co-develop a next-generation manufacturing process for long-acting injectable (LAI) drugs, using Persist’s AI-based formulation technology and Nivagen’s manufacturing capabilities. The collaboration aims…

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