from Laxxon Medical
Laxxon Medical and Adare Pharma Solutions Announce Joint Cooperation for Production of cGMP 3D Printed Oral Dosage Forms in Europe and US
Laxxon Medical and Adare Pharma Solutions Announce Joint Cooperation for Production of cGMP 3D Printed Oral Dosage Forms in Europe and US Laxxon Medical, a leading pharma-technology company pioneering a new generation of advanced oral drug delivery systems, and Adare Pharma Solutions, a global technology-driven CDMO focused on oral dosage forms, today announced a strategic partnership which enables the cGMP production of Laxxon's innovative 3D screen-printed drug delivery systems at Adare's cGMP-certified facilities. The partnership leverages Adare's global development and manufacturing expertise with Laxxon's innovative additive manufacturing technology, SPID® (Screen Printing Innovative Drug) Technology, to unlock clinical and commercial opportunities across the world, focusing on EU and US pharmaceutical markets. The underlying base technology was developed and is being provided by Exentis Group, a highly innovative technology and solutions provider based in the vicinity of Zurich, Switzerland. In 2017, Exentis granted Laxxon the worldwide exclusive license for using its proprietary 3D GMP technology platform for the development, production and commercialization of pharmaceutical application forms (Drug Delivery Systems). This technology is an additive manufacturing process which enables the development and production of complex formulations and geometrical structures of oral dosage forms through 3D screen printing to optimize the release profiles of common pharmaceuticals and new drug developments. Exentis' GMP technology platform allows for the direct upscale from small-batch clinical trials production to commercial mass production. A first Exentis GMP production system and a new bulk preparation planetary dissolver have been installed at Adare's Pessano site in Milan, Italy, and will be fully operational by end of Q4 2024. A second clinical-scale Exentis GMP production system is planned for installation at Adare's Vandalia, Ohio facility at the end of Q4 2024. "Laxxon's partnership with Adare represents a significant step forward in actualizing [Laxxon's] mission to drive disruptive global drug delivery and manufacturing solutions," Helmut Kerschbaumer, CEO of Laxxon Medical, said. "This is an essential collaboration [for Laxxon], as Adare's reputation and expertise as a technology-driven CDMO, paired with its state-of-the-art cGMP facilities, enables Laxxon in the first phase to produce clinical samples for our partners as well as for our own internal pipeline." Tom Sellig, CEO of Adare Pharma Solutions said, "Our Pessano facility provides comprehensive CDMO solutions to customers in Europe, the United States, and Asia. This collaboration with Laxxon expands our ability to provide incredible dose flexibility options such as taste masking, solubility enhancement, shape modifications for easy swallowability, and multiple APIs." The 20,400 square meter Pessano facility provides R&D services to expedite formulation and process development, with a seamless integrated transition to manufacturing. The site is capable of manufacturing a wide range of solid dosage forms at both clinical and commercial scales, including granules, capsules, and tablets. The facility is presently undergoing additional expansion to add upgraded high potency, packaging, and warehousing capabilities. About Adare Pharma Solutions Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with small molecule expertise focusing on oral dosage forms. Adare's specialized technology platforms provide taste masking, customized release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare's seven facilities in the US and Europe have developed and manufactured more than sixty-five products sold by customers worldwide. Learn more at www.adarepharmasolutions.com. About Laxxon Medical Laxxon Medical is a leading pharma-technology company and global leader of 3D screen printing (3DSP) in the pharmaceutical industry, pioneering a new generation of advanced pharmaceuticals designed to optimize drug delivery and maximize patient success through SPID®-Technology, Laxxon's 3DSP technology based on Exentis Group's extensively patented proprietary 3D technology platform. SPID®-Technology unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities in drug development and commercialization. With SPID®-Technology, Laxxon can develop and manufacture advanced versions of new and existing pharmaceutical drugs while extending and adding new patent protection through the technology transfer process. Laxxon can fully utilize the FDA's 505b(2) regulatory pathway in the US and Hybrid applications under article 10(3) of Directive 2001/83/EC in the EUR, which fast tracks product routes to market. Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 13 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing, and together with the licensed IP from Exentis Group, consisting of 230 patents and patent applications with more than 5,500 patent claims. Learn more at www.laxxonmedical.com. For more information, please visit www.laxxonmedical.com or contact: SOURCE: Laxxon Medical 10/01/2024 EQS Newswire / EQS Group AG |