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Managing the risks involved in high potency drugs manufacturing

Mark Arnold, MD of ONFAB, part of Envair Technology, describes the challenges in handling HPAPIs and how pharma manufacturers can learn to manage the risk involved.

Managing the risks involved in high potency drugs manufacturing
Published: | 4 min read

Mark Arnold, MD of ONFAB, part of Envair Technology, describes the challenges in handling HPAPIs and how pharma manufacturers can learn to manage the risk involved.

Key insights:

  • The HPAPI sector is projected to be worth $40 billion by 2027, however their increasing usage could pose a severe risk to production technicians and engineers.
  • Some HPAPIs are highly micronised and exist almost as a gas, making the risk of cross-contamination significantly worse since standard cleaning procedures may not be effective.
  • Pharma manufacturers are investing in flexible cleaning solutions that are more cost effective - the cleaning process is reduced and downtime validation is minimised.

The increasing use of high potent active pharmaceutical ingredients (HPAPIs) in cancer treatment drugs is proving highly effective in saving lives, but they can pose a severe risk to process technicians and process engineers during production – and if mistakes are made the results could be fatal.

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