ExxPharma will be responsible for technical development while Halo will have overall responsibility of drug product manufacturing and quality control at Halo’s state-of-the art GMP-compliant manufacturing facility in Whippany, NJ.
Twin screw extrusion is a highly versatile and precisely-controlled continuous manufacturing process that utilizes small mass mixing to improve efficiency, maximize quality and reduce cost.
The technology, while relatively new to the pharmaceutical industry, has been gaining wide acceptance especially with hot melt extrusion (HME) which ExxPharma and others have used effectively to improve the bioavailability of poorly soluble drug substances.
"Collaborating with Halo offers us the opportunity to serve our clients more efficiently using fully-integrated, cost-effective complementary services that encompass formulation/process feasibility studies, Phase I to Phase III clinical development and commercial production," said Isaac Ghebre-Sellassie, Founder and President of ExxPharma, which is based in Morris Plains, NJ.
"Halo has an impressive track record of manufacturing clinical trial material and commercial drug products both for U.S. and European markets. This collaboration allows us to seamlessly transfer analytical and manufacturing technologies from a research and development environment at ExxPharma to a GMP compliant manufacturing facility."
"We are excited about this collaboration with ExxPharma as it allows us to provide an alternative technology to our customers," said Lee Karras, CEO of Halo.
"Further, Isaac is a preeminent scientist in this field and having his guidance will be a tremendous asset for our customers who may face challenges with bioavailability or even want to pursue abuse deterrent technologies which HME can potentially provide," Mr. Karras went on to say.