Will offer cost-effective, high-quality production of active pharmaceutical ingredients using microbial expression systems
Enteris BioPharma, a specialist in oral peptide drug delivery technologies, has opened a 32,000ft2, US FDA inspected and cGMP compliant contract manufacturing facility in Boonton, New Jersey, US.
Equipped for high-quality production of active pharmaceutical ingredients (APIs) using microbial expression systems, Enteris BioPharma will offer services from pre-clinical to commercial scale to meet the manufacturing needs of pharmaceutical companies.
Brian Zietsman, President and CFO of Enteris BioPharma, said establishing this contract manufacturing business is 'an important milestone as the company seeks to maximise the assets and expertise acquired when it was launched in 2013'.
The company acquired the rights to Unigene Laboratories' Peptelligence oral peptide and small molecule delivery platform in 2013 after Unigene filed for bankruptcy.
Housed within the new facility is a fully integrated manufacturing plant for producing APIs at multi-kg capacity. The fermentation, purification and production support suite includes a 1,000 litre B. Braun microbial fermenter, 300ft2 Millipore TFF membranes, an Alfa Laval disc stack centrifuge, a Rainee homogeniser, a complete downstream purification suite, multiple chromatography columns, a bulk tray lyophiliser and an explosion-proof area for solvent handling and RP-HPLC.
Paul Shields, Vice President, Operations at Enteris, added: '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.'