Transparent Transfer
Kilo lab chemists and engineers predict and avoid pitfalls in early process development
For fine chemicals, the path from lab bench to manufacturing plant is a steady and careful march of process development. Midway between research and production is the kilo lab, where reactions are run for the first time at kilogram scale.
At Grace’s Fine Chemical Manufacturing Services (Grace’s FCMS), the kilo lab takes center stage. At Grace’s FCMS site in South Haven, Michigan, the kilo lab is the first stop as customers enter the site.
This kilo lab enables Grace’s FCMS scientists to efficiently transfer technology from lab scale to pilot and commercial scale.
Kilo lab teams at Grace’s FCMS manufacture products for nonclinical safety studies, preclinical toxicological programs, or early-phase clinical trials. Leveraging decades of manufacturing experience at both plants, Grace’s FCMS teams can often help customers avoid missteps that could derail manufacturing campaigns at later stages of a program.
Transparency across scales
The kilo lab team at South Haven, comprising an engineer and two chemists, runs every process at the R&D lab scale before taking it into the kilo lab. By virtue of knowing their equipment, team members can identify operations and reactions that won't translate well—or simply won't work—at kilo lab scale. This preliminary process development increases the team’s success rate once they start working in the kilo lab.
While working on a process, kilo lab groups at Grace’s FCMS sites often invite their production team colleagues to observe, train, and provide valuable input on key steps. Kilo lab chemists highlight the aspects of a synthesis that makes the process unique. Those can include the color of the reaction mixture, crystallization behavior, or the physical attributes of phase separations or distillations. Pilot plant engineers and operators gain a huge advantage when they have such information before receiving a process for scaling up to manufacturing scale.
Integration for manufacturing success
With a fully current good manufacturing practices kilo lab, Grace’s FCMS can carry its customers from early-phase R&D to Phase I clinical trial manufacturing, before it's necessary to scale up and transfer a process to the pilot plant. With Grace’s FCMS kilo lab fully integrated into its larger manufacturing ecosystem, Grace scientists and engineers can recognize key challenges and create solutions at a program’s early stages.