- BioNxt Solutions (BNXTF, Financial) consolidates its R&D at Gen-Plus CRDO in Munich, enhancing capabilities with a 1,000-square-meter state-of-the-art lab.
- The facility will advance BioNxt's lead MS treatment product, BNT23001, through bioequivalence studies.
- Gen-Plus provides advanced drug development technologies, focusing on solid and semi-solid dosage forms.
BioNxt Solutions Inc. (BNXTF), a leader in advanced drug delivery systems, has announced the integration of its research, development, and commercialization activities at the Gen-Plus GmbH & Co. KG (Gen-Plus) Contract Research and Development Organization (CRDO) in Munich, Germany. This strategic move provides BioNxt with enhanced R&D capabilities within a key European biotech hub.
The move grants BioNxt access to Gen-Plus's 1,000-square-meter cutting-edge laboratory, specifically designed for high-potency pharmaceutical development and processes compliant with Good Manufacturing Practices (GMP). This facility is equipped with advanced technologies that will support BioNxt's focus on innovative drug delivery systems, particularly for neurodegenerative diseases.
In collaboration with Gen-Plus, BioNxt will advance its lead product, BNT23001, which is a sublingual thin-film formulation of Cladribine designed for the treatment of multiple sclerosis (MS). The immediate agenda includes preparing for human bioequivalence studies, conducting placebo trials, ensuring product and technology transfer, scaling up manufacturing, and validating the active pharmaceutical ingredient analytically.
Gen-Plus, renowned for its expertise in developing solid and semi-solid dosage forms, will enhance BioNxt's capabilities with its specialized equipment and advanced technologies, including drug printing. This partnership is set to accelerate the commercialization of BioNxt's proprietary drug delivery systems and foster innovation across its therapeutic platforms.
