CMO Regis Technologies opens potent API site
The contract manufacturing organisation invested in a potent compound suite at its 36,000 sq ft cGMP site in Morton Grove, Illinois. The suite will produce potent compounds up to 1kg per batch for small molecule oncology drugs and linker payloads for antibody drug conjugates.
Construction and training of eleven staff in HPAPI handling took two years. Working with dangerous compounds means learning to use ventilated balance enclosures, containment isolators, a fog shower, and personal protective equipment.
The company said instead of choosing outside hires to lead the potent compound suite, it advertised for the position internally and used Safebridge Consultants to train supervisors.
Chemists must read more than 20 Standard Operating Procedures (SOPs) related to potent compound handling before beginning work in the controlled suite. SOPs for cGMP facilities are written documents which employees must follow perfectly without input from a supervisor to pass their training.
