TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announced that it has expanded its engagement with one of its Contract Manufacturing Organization (CMOs), Experic, LLC, with an agreement to install a Thin Film Freezing processing line and its associated capabilities at Experic’s cGMP facility in Cranbury, New Jersey.
Installation of TFF’s custom-designed equipment is expected to be complete in early Q2-2021. This will increase TFF’s manufacturing capacity, as well as provide a third cGMP manufacturing location for the company.
“This expansion of our manufacturing operations at Experic gives us the capability and capacity to develop and produce additional products currently in assessment with pharmaceutical company partners,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “Experic has been a terrific partner for us because of their domain expertise in dry powder inhalation products. They also provide us with unique downstream encapsulation technology that rounds out the specialized manufacturing requirements of our dry powder inhalation therapies.”
“The entire Experic team is thrilled to be working with TFF Pharmaceuticals and supporting development and manufacturing activities using its Thin Film Freezing (TFF) technology,” said Jeffrey P. McMullen, Chairman and CEO of Experic. “We share their excitement in the continued advancement and expansion of their technology and business.”
Experic, a contract manufacturing organization (CMO) and pharmaceutical supply services company, supports every phase of a product’s life cycle from clinical to commercial scale, across a range of dosing and packaging formats, including capsule filling, powder and pellet dosing (including DPI), and autoinjectors and pen assemblies. Utilizing cutting-edge Harro Höfliger equipment in our state-of-the-art Class A GMP facility and build-to-suit suites, we manage global delivery of the highest quality products, even for expedited projects, while providing unparalleled knowledge, expertise and customer service.
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 per cent.