Enteris BioPharma Inc., specializing in oral peptide delivery, will now provide contract manufacturing within its 32,000-square-foot, FDA-inspected and cGMP compliant facility in Boonton, New Jersey.
The company says it is equipped to ensure cost-effective, high-quality production of API using microbial expression systems and offers pharmaceutical companies a full array of services to meet their manufacturing needs, from pre-clinical to commercial scale.
“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,” said Brian Zietsman, president and CFO.
Housed within its facility is a fully integrated manufacturing plant for producing API at multi-kilogram capacity. The fermentation, purification and production support suite includes a 1,000 liter 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 lyophilizer 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 program support, ranging from small scale pre-clinical programs to commercial scale API manufacturing.
"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," says Paul Shields, Ph.D., vice president, operations of Enteris.
For more information, visit www.EnterisBioPharma.com.