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MJH Life Sciences
MJH Life Sciences

Dear %%=ProperCase(FirstName)=%%,

Digital modeling and simulation and Process Analytical Technology (PAT) help advance highly-potent molecule development

Highly potent API (HPAPI) are playing a growing role in the small molecule pipeline due to their usefulness in treating cancer and other indications. As these compounds have a physical and clinical effect at very low dose, they pose potential occupational health risks. Personnel in development and production facilities must be protected at all times from the products they manufacture. The sustainable production of highly potent APIs (HPAPIs) therefore requires specific precautions for operator health and safety on the one hand and for product quality on the other. The CDMO industry has responded with increased contained manufacturing capacity.However, a range of technological tools can help approach the wide variety of HPAPI process development needs. Digital technologies that can help safely and effectively advance HPAPI production at various points in the development process include:

  • Digital modelling and simulation

  • Process Analytical Technology (PAT)

  • Automated visual assessment and documentation

  • Virtual and augmented reality

  • Machine learning and data analysis

For more information about Lonza’s best practices for HPAPI developed over a 20+ year track record, please download the resources offered below.

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