Pharma Focus Asia

Enteris BioPharma Completes Expansion of Manufacturing Facility and Announces Launch of CDMO Business Segment

Tuesday, May 04, 2021

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation, today announced the expansion of its Boonton, NJ manufacturing facility and the launch of its CDMO business segment, providing custom solutions for the formulation, development and manufacturing of solid oral doses for difficult to formulate BCS III and IV compounds, including peptides and highly potent compounds. Enteris now provides bench to market services, including the development, manufacture, testing and release of Phase 1 to Phase 3 clinical trial supplies, and commercial production.

The expanded 32,000-square-foot facility includes 6,000 square feet of cleanroom space with approximately 2,500 square feet dedicated to the containment and processing of high potency API (HPAPI).  

"This is a significant accomplishment for Enteris that plays a key role in our future growth plans," said Rajiv Khosla, Ph.D., Chief Executive Officer of Enteris. "Our purpose-built manufacturing facility now has the wherewithal to produce CTM through to Phase 3, as well as product for commercial launch. These enhanced capabilities position Enteris to take advantage of a variety of growth opportunities, and it is our intent to maximize this potential to the fullest. The expansion allows Enteris to seek deeper development and manufacturing relationships with partners by providing custom solutions from bench to market."

The manufacturing plant's HPAPI containment area is designed to safely handle highly potent APIs. Depending on the solid oral dosage unit's physical characteristics, batch sizes can vary from a few hundred to hundreds of thousands of dosage units. The facility also includes 1,700 square feet of flexible suite space that can be adapted to a partner's development and manufacturing needs.

"Delivering on a construction timetable amid the COVD-19 pandemic was no easy feat, and the team at Enteris is to be congratulated for meeting the challenge," stated Paul Shields, Ph.D., Chief Operating Officer for Enteris. "We look forward to leveraging the enhanced manufacturing capabilities to deepen existing manufacturing relationships and bolster our ability to secure new high-value relationships with companies seeking CDMO capabilities in the U.S., regardless of whether the product is a solid oral formulation using our proprietary oral formulation technologies, Peptelligence® or ProPerma™, or other tablet technology."

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