Leveraging innovations in plasmid manufacturing to bring advanced therapies to market

Recent increases in commercial utilizations for plasmid DNA have triggered the need for increased capacity, as well as clarity on appropriate application of regulatory guidance and GMP principles in the manufacturing process.

This whitepaper provides insights on market trends influencing the supply of pDNA for advanced therapies, as well as manufacturing strategies to help accelerate timelines, mitigate risk, and optimize clinical outcomes. Specific topics include:

• Regulatory recommendations on use of GMP raw materials in advanced therapy manufacturing processes
• Critical quality attributes of plasmid DNA for advanced therapy applications
• Guidance on implementation of GMP principles for plasmid manufacturing using a risk-based approach

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