Table 2: Avoiding delays in clinical manufacturing of drug product
Manufacturing issues were the primary reason given for non-approvals in many of the response letters issued by the FDA in 2016. These manufacturing issues not only delay drug development, but also complicate the relationship between drug firms and their contract manufacturers. We will discuss the common issues, including planning, risk management, selection of primary packaging & materials, contract documents, and guidelines for choosing the right partner that can offer the quality necessary for successful clinical manufacturing. A trustworthy CDMO supports you with realistic project timelines and a framework of high product quality, while you focus on your core competencies of discovery and clinical development.