C&EN Whitepaper
Challenges and Opportunities in High-Potency Pharmaceuticals Manufacturing
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High-potency drugs derived from natural products command a large and growing market share in the pharmaceutical industry. The rich diversity of potent natural products necessitates a range of manufacturing demands. Because HPAPIs are so potent, requiring very little substance to elicit sufficient effect, it is critical to protect employees working with them, as well as the environment. The investment in hardware and expertise to contain these products and measure the effectiveness of that containment is a substantial barrier to entry.

Key Objectives:

  • HPAPIs derived from natural products are a growth market
  • HPAPIs require special safety considerations during manufacture to protect employees and the environment
  • Manufacturing high-potency natural products at U.S. Food and Drug Administration quality standards requires a systematic quality by design (QbD) approach

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