Enteris BioPharma, a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation, has expanded its Boonton, NJ manufacturing facility and at the same time launched its contract development and manufacturing organization (CDMO) business segment.
 
Enteris’ capabilities include 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, CEO 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,” said Paul Shields, chief operating officer, 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.”