Tech transfer and scale-up can be challenging and lead to significant costs and delays if problems occur. With kilo lab, pilot plant, and production operations located on the same campus, tech transfer and scale-up can be de-risked and accelerated. Grace Fine Chemical Manufacturing Services (FCMS) has taken this approach at both of its production facilities and combined these advantages with a focus on quality and safety.
Integrated RSM and API Manufacturing
Grace FCMS manufactures high-quality APIs for a range of custom and generic products at the South Haven, Michigan site. Our success in production is a result of our robust R&D, analytical services, engineering, quality, and operations teams. These capabilities are bolstered by the integration of operations between our cGMP manufacturing facility in South Haven, which produces APIs, and our ISO fine chemical facility in Tyrone, Pennsylvania, which can produce regulatory starting materials (RSMs) used in manufacturing our APIs. This integration simplifies the supply chain and creates unparalleled transparency for the starting-materials production process, allowing us to secure the logistics and implement processes to identify and control impurities earlier in the API manufacturing process. The teams at the South Haven and Tyrone sites work together to identify process opportunities, set production schedules, and address logistical issues.