Arch Biopartners engages Catalent to begin manufacturing process for AB569
Preparations underway for the first human trials involving patients with antibiotic resistant lung infections.
Arch Biopartners has engaged Catalent Inhalation, a division of Catalent Pharma Solutions (Catalent), to begin the manufacturing process for its drug AB569 in preparation for the first human trials involving patients with antibiotic resistant lung infections.
Catalent Inhalation will commence with initial stability and formulation studies, which are both important production milestones in preparing a pharmaceutical product for human trials and eventual drug approval by the FDA and other health authorities.
Once the stability and formulation work is completed with positive results, Arch will engage Catalent Inhalation to manufacture a supply of AB569 that meets good manufacturing practice standards to enable human trials to treat cystic fibrosis and chronic obstructive pulmonary disease patients with chronic bacterial lung infections.
Jonathan Arnold, Vice President and General Manager for Advanced Delivery Technologies commented: "We are pleased to support Arch Biopartners' program from our recently expanded facility in Morrisville, North Carolina, Catalent's Centre of Excellence in the development and manufacture of inhaled dose forms."
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