Laureate opens new preclinical protein facility

Laureate Pharma, a USA-based full service biopharmaceutical development and protein production company, has formally opened its newly-constructed pilot plant in Princeton, New Jersey, for preclinical manufacturing. The plant is now available for early engineering runs and production of product for uses such as formulation and toxicological testing, the firm noted.

The facility, which is designed for process development, production and purification of early-phase preclinical proteins, also features 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 already-existing certified Good Manufacturing Practices production facility and equipment, the company stated.

The pilot plant includes both stainless-steel, stirred-tank bioreactors and disposable, single-use bioreactors - the same technologies used in Laureate's larger-scale, cGMP manufacturing facility, while the purification suites also feature the same process chromatography and filtration technologies used in the cGMP facility.