TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today 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."
About Experic Services
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.
About TFF Pharmaceuticals’ Thin Film Freezing technology platform
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 percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder versions of Voriconazole and Tacrolimus and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that results obtained in preclinical studies and clinical trials may not be indicative of results obtained in future clinical trials; (ii) the risk that the Company’s product candidates may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and Tacrolimus, (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (viii) those other risks disclosed in the section "Risk Factors" included in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
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TFF Pharmaceuticals, Inc
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TFF Pharmaceuticals, Inc.
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