Approaching 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