As a specialist in small molecule drug substance for more than 40 years, Grace FCMS supplies regulatory starting materials (RSMs) and intermediates as well as custom active pharmaceutical ingredients (APIs). What separates Grace FCMS from other suppliers is the fact that we develop and manufacture our products at domestic U.S. facilities.
We have all the technology needed to manufacture, scale-up and supply high-quality RSMs and intermediates from our Tyrone, Pennsylvania facility. This does not require cGMP certification; however, South Haven provides uniform quality assurance across both sites, and Tyrone develops these materials efficiently under a quality management system aligned to meet FDA and ICH requirements.
We offer a very wide range of chemistries serving small molecule APIs, including some special capabilities such as cryogenic reactions. Some of the chemical transformations demanded by today’s complex therapeutic drugs require cGMP manufacturing in cryogenic conditions, which in pharmaceuticals refers to temperatures below –80ºC.
Grace FCMS has the capability to run processes at cryogenic conditions of –90ºC, which helps to eradicate impurities, handle highly reactive compounds, improve reaction selectivity, mitigate unwanted secondary reactions, limit volatility for greater safety, and prevent ice crystals. Processes that run under these conditions are sensitive; it is experience and know-how that differentiates Grace FCMS and brings value to our customers.
Ultra-Low Vacuum Technology
Grace FCMS also offers the capability with ultra-low vacuum technology to go to 1mmHg or less on a fractional distillation, enabling the separation of components at lower temperatures and pressure.