Arch Biopartners starts GMP manufacturing for AB569 at Dalton Pharma Services
Company will be responsible for the GMP preparation and filling of AB569 into glass vials.
Arch Biopartners has announced Dalton Pharma Services has launched the GMP campaign for AB569, the company's inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs.
Dalton will be responsible for the GMP preparation and filling of AB569 into glass vials. These vials will then form part of the clinical kits required to support the Phase I safety trial for AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) later this year.
Catalent Inhalation, a division of Catalent Pharma Solutions, (Catalent) previously completed the initial stability and formulation studies for AB569, which were both important production milestones in preparing a GMP pharmaceutical product for human trials and eventual drug approval by the FDA and other health authorities.
Catalent will continue to be involved in the final testing of the GMP supply of AB569 once the vial filling is completed by Dalton to enable the release of the final drug product. As these tasks near completion, Arch management expects to provide updates regarding the expected delivery time of the drug product to CVAMC to enable the start of the phase I safety trial.
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