SemBioSys Genetics completed a technology transfer and manufacturing agreement with Cangene for the processing and purification of SemBioSys' plant-produced insulin. The contract is part of the company’s preparations for its IND and the initiation of clinical trials. Cangene will manufacture insulin for SemBioSys’ preclinical and early stage clinical development.
With the signing of the contract, SemBioSys officials say they intend to immediately begin work with Cangene to implement technology transfer of the manufacturing process, which enables cGMP production of insulin from transgenic safflower. Cangene will be responsible for purification of clinical grade material isolated from safflower seed produced by SemBioSys’ proprietary production technology.
According to SemBioSys, demand for insulin for the treatment of diabetes reached an estimated 5,500 kilograms in 2005 and is projected to increase to 16,000 kilograms by 2012. SemBioSys believes its safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by 70% and product costs by 40%. In addition, because of the ease in scaling-up crop acreage, plant-produced insulin offers significant improvements in the flexibility and speed of scaleup, says Andrew Baum, president and CEO of SemBioSys Genetics.