BioNxt Solutions has announced the integration of its research, development and commercialisation activities with the Gen-Plus GmbH & Co. KG (Gen-Plus) Contract Research and Development Organization (CRDO) in Munich, Germany.
The move provides BioNxt with enhanced research and development capabilities, collaboration opportunities, and accelerated innovation potential within a major European biotech hub.
The company seeks to leverage the advanced and innovative infrastructure of the Gen-Plus Laboratory and harness the facility’s 1,000 square metres of state-of-the-art space designed for high-potency active pharmaceutical ingredients and GMP-compliant processes.
How specialised facilities will advance research and development
The lab’s specialised equipment, including advanced technologies for solid and semi-solid dosage forms and capabilities in drug printing, will empower BioNxt to maximise the potential of its proprietary drug delivery systems, neurodegenerative disease therapeutics, and next-generation biomedical technologies.
In the coming weeks, BioNxt and Gen-Plus will be working together closely and focused on the development and commercialisation of the Company’s lead product, BNT23001, a sublingual thin-film formulation of Cladribine for the treatment of multiple sclerosis (MS).
Preparation activities for the planned human bioequivalence study include placebo trials, product and technology transfer, upscaling of manufacturing, and analytical validation of the active pharmaceutical ingredient.
About Gen-Plus GmbH & Co. KG
Gen-Plus, headquartered in Munich, Germany, is a premier Contract Research and Development Organization (CRDO) with over 25 years of experience in pharmaceutical formulation and development.
The company operates a 1,000-square-metre state-of-the-art laboratory equipped for handling high-potency active pharmaceutical ingredients and licensed for GMP-compliant production, including narcotics.
About BioNxt Solutions
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialisation efforts, primarily focused on European markets.
