Enteris BioPharma Launches Contract Manufacturing
News Feb 11, 2015
Enteris BioPharma, Inc. has announced the launch of 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 maximize the assets and expertise that we acquired when the company was launched in 2013.”
Housed within Enteris BioPharma’s 32,000 square foot 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.
Paul Shields, Ph.D., 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.”
APC Protein Deletion Disrupts Cell Signalling and Could Cause AutismNews
Researchers show deletion of the protein APC in progenitor cells leads to massive disruption of brain development and a signaling cascade previously linked to genes associated with autism.READ MORE
SCIEX Receive Science and Technology Award at HUPO 2017News
Two researchers from SCIEX received the HUPO 2017 award at the 16th Human Proteome Organization World Congress in Dublin, Ireland.READ MORE
$2.5M Contract Awarded to ChromaTan to Develop Continuous Purification PlatformNews
ChromaTan Corporation, a provider of continuous and single-use chromatography solutions for the biotechnology industry, has been awarded a $2.5M contract from the Food and Drug Administration (FDA).READ MORE