Therapure Biomanufacturing Awarded Manufacturing Contract for Insmed’s ARIKAYCE™
Mississauga, Ontario, Canada (April 29, 2014) – Therapure Biomanufacturing, a division of Therapure Biopharma Inc., announced today the signing of an agreement with Insmed Incorporated for the manufacture of ARIKAYCE, liposomal amikacin for inhalation.
Therapure Biomanufacturing is an integrated contract development and manufacturing organization (CDMO) focused on biologic and high value therapeutics that can provide new options for patient care. Under this agreement, Therapure will be responsible for the construction of a custom manufacturing suite for scale-up, commercial aseptic formulation and fill/finish manufacturing of Insmed’s ARIKAYCE at the Therapure facility in Mississauga, Ontario. Innovative technologies, such as the proprietary liposomal encapsulation process utilized in ARIKAYCE, are complementary to Therapure’s capabilities in the cGMP manufacturing of complex therapeutics.
Mr. Nick Green, Therapure’s President and Chief Executive Officer, said: “We are delighted to partner with Insmed to assist with the advancement of this innovative technology for serious and life-threatening pulmonary diseases. Therapure prides itself on its development, clinical and commercial cGMP manufacturing expertise providing solutions for biologic therapeutics and innovative drug delivery technologies, which make a difference in patients’ lives.”
“Insmed looks forward to working with Therapure for the commercial supply of our key drug candidate ARIKAYCE. Therapure’s proven cGMP manufacturing capabilities and expertise with aseptic formulation will support the planned global commercial launch of ARIKAYCE,” said Dr. Peter Clarke, Insmed’s Vice President of Technical Operations.
Therapure Biomanufacturing is the award-winning contract development and manufacturing division of Therapure Biopharma Inc. offering integrated services for developing, manufacturing, purifying and packaging complex biological therapeutics and technologies. Our scientific and manufacturing expertise, as well as our flexible state-of-the-art cGMP facility, provides clients with optimal biomanufacturing solutions to advance their therapeutics from discovery to market.
Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of Therapure Biomanufacturing, the contract development and manufacturing division and Therapure Innovations, the proprietary therapeutics and platform technologies research and development division. Therapure Biopharma Inc.’s 130,000 sq. ft. facility includes research laboratories, cGMP biomanufacturing and aseptic fill/finish suites, as well as quality control laboratories built to meet FDA (USA), HPFB (Canada) and EMA (Europe) standards.
Insmed Incorporated is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. Insmed is focused on the development and commercialization of ARIKAYCE, or liposomal amikacin for inhalation, for at least two identified orphan patient populations: patients with nontuberculous mycobacteria (NTM) lung infections and cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections.
For more information, please visit: www.therapurebio.com
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