Co-Processed API

Pharmaceutical researchers, regulatory and materials scientists and manufacturing colleagues from industry, academia, and regulatory agencies are invited to attend a workshop on co-processed API on July 13 and 14, 2022, from 8:30 a.m. to 4:30 p.m. (EDT).

The event will be held in person at the University of Maryland, Baltimore School of Pharmacy, located at 20 N. Pine St. Baltimore, MD 21202. However, a virtual option will be made available although on site attendance is encouraged to facilitate the discussion and networking (pending any changes due to a COVID-19 situation). A networking event will be planned in the evening after day 1 for those able to travel.

This two-day workshop will examine recent advances in co-processed API as a technology to improve drug-substance physical-chemical properties and drug product manufacturing process robustness and explore proposals for enabling commercialization of these transformative technologies. Regulatory considerations will also be discussed with a focus on regulatory classification, regulatory CMC strategies and CMC documentation supporting the use of this class of materials for clinical studies and commercialization.

FOR MORE INFORMATION:

More information about this event is available at https://www.pharmacy.umaryland.edu/centers/cersievents/co-processed-api