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Chasing the Nanogram Limit



WEBINAR

HPAPIs are a rapidly expanding group of therapeutics due to the recent commercial approvals of 8 ADCs and other targeted therapies. As the potency of these new compounds increases, API manufacturers are challenged to evolve their equipment, facilities, and processes to keep up with the industry.

In recent years, the pharmaceutical industry has been moving toward drugs with increasing potency, including ones with OELs in the single nanograms/m³. This shift is occurring as a result of better-targeted therapies in the oncology space as well as due to more toxicological data about previously approved APIs. With much of this work being outsourced, many contract manufacturing organizations wishing to operate in this field have had to update their processes to handle these materials and ensure the safety of their operators. In this presentation, we will show how Merck has met these challenges and is preparing to lead in this area moving forward.

In this webinar, you will learn:

  • the evolution of the high potent API manufacturing industry from 10 µg to single nanogram limits
  • different safety concepts to handle highly potent compounds
  • about the most commonly used payload classes in the ADC field

Speaker

John Stevens

John Stevens

Merck

Field Marketing Senior Specialist, Actives & Formulation

John Stevens joined the company in 2004 and held a variety of positions in our HPAPI facility, focusing on project leadership in the scale up and first-time GMP production of HPAPIs and complex APIs and lead the site MSAT team for 3 years. In 2019 he took on a role as a Field Marketing Senior Specialist for the Actives & Formulation. John supports the A&F business in the Americas, advising our customers around contract manufacturing services and containment topics.

John studied Synthetic Organic Chemistry and received his Master's degree from the University of Wisconsin.