Laureate Pharma formally opened its newly constructed pilot plant in Princeton, NJ, for preclinical biopharmaceutical manufacturing. The plant is now available for early engineering runs, production, and testing for formulation and toxicological data.
The pilot plant is designed for process development, production, and purification of early-phase preclinical proteins. The facility also contains two separate production suites and two expanded purification suites to support preclinical production of recombinant proteins from mammalian-cell culture.
The suites mimic Laureate’s existing production facility and equipment. The pilot plant includes both stainless-steel, stirred-tank bioreactors and disposable, single-use bioreactors. The purification suites also run with the same process chromatography and filtration technologies used in the cGMP facility.
“The equipment in our pilot plant facility is designed to facilitate a direct, seamless scale-up from development to cGMP production for our clients' projects,” says Robert Broeze, Ph.D., Laureate’s president and CEO. “With the new pilot plant in operation, we can accelerate our manufacturing of preclinical material and save on several months worth of critical product development time.”