Regis Technologies, a Morton Grove, IL-based CMO, has opened a new suite for manufacturing highly potent APIs.
Construction of the PCS facility, which provides for small molecule cGMP manufacturing of up to one kilogram per batch, took about two years, Area Development reported. During that time, the manufacturing team went through training on how to handle the potent compounds, which target small molecular oncologicals and linker payload projects for antibody drug conjugates.
With the new suite, Regis hopes to expand its cGMP offering in the oncology market.
"We see the PCS as an important asset to serve the growing oncology market as more companies look to advance their lead candidates into the clinic," Wayne Nowicki, Regis' director of business development, said in a statement.
Proper handling of potent compounds requires the use of specialized facilities that are carefully designed to minimize containment risks. The new PCS facility includes isolators, laminar flow hoods and local exhaust ventilation appropriate for potent compound handling, the company said.
- read the Area Development story