The contract, awarded by Australia's Agenix Limited, is to make clinical trial materials and potentially commercial supplies of ThromboView, in development for the detection of blood clots in deep vein thrombosis and pulmonary embolism.
The new contract is good news for Diosynth, which has been hard hit by overcapacity in the marketplace for contract production of biopharma ingredients. Two separate market research studies - one from Frost & Sullivan and another from High-Tech Business decisions - have found that capacity is outstripping demand for biologics manufacturing over the last few months, overturning the previously held notion that the sector was heading for a long period of undercapacity.
Over the past twelve months, Agenix and Swiss company ExcellGene have been working to increase the productivity of the cell line used to produce ThromboView 10-fold, bringing the project to the level of small-scale manufacture.
Now, the deal with Diosynth will continue this process development work and scale-up to the manufacturing levels needed for pivotal trials and, if approved, commercial sale of the product.
Agenix transfer the manufacturing process developed so far to the Research Triangle Park facility of Diosynth Biotechnology for further process refinement and cGMP manufacturing. The goal of the collaboration is to enable Agenix to supply cGMP material for Phase III clinical trials by the third quarter of next year.
Thromboview takes the form of a clot-binding humanised monoclonal antibody attached to a radiolabelled marker molecule, and is injected into a patient with a suspected DVT or PE to help guide treatment. It is currently in Phase II testing in DVT patients in Canada and the US, and recently started a Phase Ib trial in PE patients in Australia.
Agenix also said it plans to have a sales, marketing and distribution agreement for the product in place by the end of the year.