Enteris BioPharma, Inc., a provider of formulation services for proprietary drug delivery technologies, including oral peptide drug delivery, has launched contract manufacturing within its 32,000-square foot facility in Boonton, New Jersey for the production of active pharmaceutical ingredients (APIs) using microbial expression systems. The contract manufacturing services cover preclinical to commercial scale. The facility is FDA-inspected and GMP-compliant.

The fully integrated manufacturing plant within the Boonton facility can produce APIs at multi-kilogram capacity. The fermentation, purification, and production support suite includes a 1,000 liter B. Braun microbial fermenter, a 300 sq. ft. Millipore TFF membranes, an Alfa Laval disc stack centrifuge, a Rainee homogenizer, a complete downstream purification suite, multiple chromatography columns, a bulk tray lyophilizer, and an explosion-proof area for solvent handling and RP-HPLC.

Brian Zietsman, President and chief financial officer of Enteris BioPharma, commented: “The initiation of our contract manufacturing business is an important milestone for Enteris as we seek to fully maximize the assets and expertise that we acquired when the company was launched in 2013.”

Source: Enteris BioPharma