Grace Invests in Small Molecule API Expansion

W. R. Grace & Co., a provider of specialty silica and fine chemicals, is proceeding with an expansion of its contract development and manufacturing (CDMO) facility in South Haven, MI.

The expansion will bring a new 4,000-gallon multi-use reactor train consisting of glass lined and stainless-steel materials of construction. The expansion will also include a HASTELLOY centrifuge to facilitate product isolation, which enhances the commercial capability of the cGMP-compliant site.

The project will bring South Haven up to three 4,000-gallon multi-use reactor trains enabling Grace’s Fine Chemical Manufacturing Services (FCMS) business to support continued growth of its small molecule drug production including custom active pharmaceutical ingredients (APIs), cGMP intermediates and generic APIs. The project is estimated for completion in January 2024.

In June 2021, Grace acquired the FCMS business from Albemarle as part of an expansion to support its pharmaceutical portfolio. The acquisition enabled Grace’s Materials Technologies division to triple its fine chemical footprint while leveraging its existing chromatography resins and formulation excipients in the health and life sciences markets.

“The growth strategy of our company is aligned to support the success of our customers,” said Bob Patel, CEO, Grace. “Our South Haven expansion demonstrates this commitment and addresses the increased market demand in small molecule drug substance manufacturing that has taken place year over year in the past decade. Anticipating the needs of the market, coupled with our expertise, are key Grace capabilities that work together to enable customer success.”

Sandra Wisniewski, president, Grace Materials Technologies, said, “The FCMS business has a promising growth trajectory being a leading CDMO in North America. The additional capacity created through this project will enable our customers to develop critical drug therapies in areas such as oncology, diabetes, cardiovascular and antivirals.”

Grace’s FCMS is a leading North American CDMO offering extensive capabilities for the pharmaceutical, nutraceutical and fine chemical industries. Its network of three fully integrated sites offer an industry-leading flexible supply chain through the back integration of its intermediates.