Manufacturing Drugs with Highly Potent APIs

Overview

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In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs), including:

  • a review of the relevant guidance
  • HPAPI classification systems
  • safety processes to minimize exposure risk
  • equipment and methods to prevent cross-contamination
  • how to ensure GMP compliance for regulatory submissions

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Related Topics

APIs (active pharmaceutical ingredients)Contract ManufacturingDrug delivery, formulation

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