SAFC plans to construct a cGMP highly potent active pharmaceutical ingredients (HPAPIs) conjugation suite at its St. Louis, MO, manufacturing site. This addition will support oncology drug substance requirements that demand a combination of small molecule chemistry, containment engineering, highly regulated biologics manufacturing, and extensive quality control capabilities, the company notes.
“Adding HPAPI conjugation capacity enables SAFC to further vertically integrate our contract manufacturing services to pharmaceutical companies that are developing novel cures for cancer,” states SAFC president, Frank Wicks.
A significant portion of SAFC’s business has been in the production of small molecule HPAPIs and in performing nonpotent conjugations. The company says that adding specialized high-containment biologic capacity for performing potent conjugations is a logical extension. In about a month, SAFC has reported efforts worth $33.5 million to expand HPAPI facilities in Israel and Wisconsin.
The new 600 sq. ft. facility at St. Louis is expected to be operational later this year. It will enable the conjugation of HPAPIs to a variety of targeted delivery molecules. SAFC points out that the suite will be able to accommodate early-stage clinical supplies of potent conjugated APIs with capabilities to expand production into commercial-scale and handle multikilogram quantities of conjugated HPAPIs per batch.