C&EN White Paper
Supporting highly potent pharmaceutical development with manufacturing flexibility
Brought to you by Aenova

Low doses of highly potent active pharmaceutical ingredients (HPAPIs) treat cancer, autoimmune diseases, and other medical conditions, often with reduced side effects. Because these compounds can have a major cytotoxic effect in even tiny amounts, their safe handling is a challenge for personnel during manufacturing. Drug manufacturers must take precautions at every step of production.

Those safeguards can seem burdensome when flexibility to handle to handle different substances, formulations, batch sizes and production processes is critical to keeping a drug development project on track, on time, and on budget. Partnering with a contract development and manufacturing organization with expertise in safely handling HPAPIs can be a valued asset in the development process.

Key Objectives:
  • Discover the unique manufacturing challenges presented by HPAPIs during drug development.
  • Understand the special precautions needed to ensure operator safety when working with HPAPIs.
  • Learn how to incorporate flexibility into manufacturing facilities, processes, and equipment to enable efficient optimization and scale up during HPAPI development.

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