Dalton Pharma Services, a contract development and manufacturing oirganization of both active ingredients and drug products, will provide formulation development, cGMP powder and liquid filling, analytical method development and validation, and quality-control release testing, in support of Arch Biopartners’ GMP manufacturing campaign for AB569, an inhalation drug candidate for treating antibiotic-resistant bacterial lung infections, which frequently afflict patients with chronic obstructive pulmonary disease and cystic fibrosis.

Arch Biopartners, a Toronto-based pharmaceutical company, has received orphan drug designation for AB569 from the US Food and Drug Administration for treatment of cystic fibrosis patients with Pseudomonas aeruginosa infections and an orphan medicinal product designation from the European Medicines Agency for the treatment of cystic fibrosis patients.

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, previously completed the initial stability and formulation studies for AB569, which were production milestones in preparing a GMP pharmaceutical product for human trials for eventual drug approval review.

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.

Source: Dalton Pharma Services and Arch Biopartners