The Chicago-based company will manufacture materials for small molecule oncology drugs, and linkers and payloads for antibody drug conjugates. A Potent Compound Suite will allow cGMP manufacturing up to 1kg per batch.
HPAPI production requires specialised facilities to minimise contamination risks. The site is equipped withisolators, laminar flow hoods and local exhaust ventilation.
The facility has a containment performance target (CPT) set to 50 ng/m3, based on the occupational exposure limits (OELs) of the specific APIs to be manufactured there.
Regis already operates a 36,000 sq ft cGMP facility in Morton Grove, Illinois. As well as cGMP API manufacturing, it performs chiral separations, scale-up, and commercial manufacturing.