Enteris BioPharma Launches Contract Manufacturing within 32,000-Sq Ft, FDA inspected and cGMP Compliant Facility

Enteris BioPharma, has launched contract manufacturing located within its 32,000 square foot, FDA inspected and cGMP compliant facility in Boonton, New Jersey.

Equipped to ensure cost-effective, high-quality production of API using microbial expression systems, Enteris BioPharma offers pharmaceutical companies a full array of services to meet their manufacturing needs, from pre-clinical to commercial scale.

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

Housed within Enteris BioPharma’s 32,000-sq ft facility is a fully integrated manufacturing plant for producing API at multi-kilogram capacity. The fermentation, purification and production support suite includes a 1000-L B. Braun microbial fermenter, 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 lyophiliser and an explosion proof area for solvent handling and RP-HPLC. Enteris BioPharma’s manufacturing capabilities are strengthened by significant technical expertise that enables the company to offer end-to-end programme support, ranging from small-scale pre-clinical programmes to commercial-scale API manufacturing.

Paul Shields, Vice President, Operations of Enteris, remarked: “From fermentation to harvesting and downstream purification through to stability testing, process validation, QA and regulatory support, Enteris has the technological capability and expertise to meet a wide array of customer needs and project specifications. With the initiation of our contract manufacturing services, Enteris offers pharmaceutical partners the ability to manufacture recombinant peptide and protein products using microbial expression systems in an FDA inspected and cGMP compliant facility located in New Jersey.”