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Nitrosamine Testing: The Regulatory Aspects
September 17th 2020Detection of N-Nitrosodimethylamine (NDMA) impurities has led to regulatory warnings and product recalls. Pharmaceutical manufacturers must adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
Manufacturing Biopharmaceuticals from Start-up to Commercialization
September 3rd 2020This ebooklet walks through the steps required to take a biologic/biopharmaceutical product forward to commercial manufacturing. It distinguishes between a drug and biologic, which is key to understanding the complex requirements for biologics development and manufacture.