A new suite for HPAPI conjugate production was added to St. Louis plant and a new reactor was installed at Arklow site.
SAFC Pharma of the Sigma-Aldrich group reports that it has a new suite at its St. Louis, MO, facility that will produce high-potency API (HPAPI) conjugates for cancer drug development and a new reactor at its Arklow, Ireland, site that will expand large-scale manufacturing by approximately 15%.
The 600 sq. ft. suite at the St. Louis campus will enable the conjugation of HPAPIs to a variety of targeted delivery molecules including mAbs, the company explains. It can also accommodate early-stage clinical supplies and multikilogram quantities, with the capability to expand production up to commercial-scale.
In Arklow, the $4 million project involved the installation and start-up of a 6,000 L Hastalloy® reactor for large-scale API production, increasing the total capacity at the site to 96,000-liter, with a reactor range from 250 to 8,000 liters. Both large- and small-scale manufacturing is possible. The 209,000-cubic-feet Arklow complex is cGMP, FDA, and IMB inspected as well as fully validated, the company notes.