MDGH-Funded Manufacture of selected formulations

The objective of this work package is to manufacture up to three paediatric formulations of moxidectin at small scale, select one formulation to be manufactured to cGMP, and to manufacture and release that formulation as Clinical Trial Material. MDGH will fund and lead this work package.

Candidates for small-scale development will be selected on the basis of meeting required target product characteristics. These selections will be re-assessed as the development program progresses and the formulations manufactured are characterised against the target product characteristics using validated methods. The physicochemical characteristics, manufacturability, and suitability of current drug product release/stability assays formulations will be assessed. Small scale batch manufacture will be performed at University of Strathclyde.

Following completion of the small-scale batches, one candidate for full scale manufacture will be selected, taking into account the findings from WP2 where possible. A full-scale batch will be manufactured under cGMP conditions, tested and released and put onto stability under both accelerated and standard conditions. Clinical trial material that meets specifications will be packaged  appropriately and labelled as required for the clinical trial in WP4.