Dalton to Start GMP Mfg. for Inhalation Drug Candidate

Dalton Pharma Services has launched the good manufacturing practice (GMP) campaign for Arch Biopartners’ AB569, an 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, (www.catalent.com), 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.