Laureate Pharma has officially opened its newly constructed Pilot Plant in Princeton, NJ for pre-clinical biopharmaceutical manufacturing. The plant is now available for early engineering runs and product production for uses such as formulation and toxicological testing.
The plant is designed for process development, production and purification of early-phase preclinical proteins. The facility features two separate production suites and two expanded purification suites to support preclinical production of recombinant proteins from mammalian-cell culture. The plant includes stainless steel, stirred-tank bioreactors and disposable, single-use bioreactors. The purification suites feature the same process chromatography and filtration technologies used in Laureate's larger scale 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," said Robert Broeze, Ph.D., Laureate's president and chief executive officer. "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."