SemBioSys signs up CMO for plant-produced insulin
Canadian biotech company SemBioSys Genetics has agreed a technology transfer and manufacturing agreement with biopharmaceutical company and contract manufacturer Cangene Corporation, for the processing and purification of its plant-produced insulin.
Canadian biotech company SemBioSys Genetics has agreed a technology transfer and manufacturing agreement with biopharmaceutical company and contract manufacturer Cangene Corporation, for the processing and purification of its plant-produced insulin.
The deal will enable the cGMP production of insulin from transgenic safflower. The contract is part of the SemBioSys' preparations for its Investigational New Drug Application (IND) and the initiation of clinical trials. Cangene will manufacture insulin for both preclinical and early stage clinical development.
SemBioSys believes its safflower-produced insulin can reduce capital costs compared with 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 scale-up.
Andrew Baum, president and ceo of SemBioSys said: "We continue to advance our insulin development plan. In the near term, we expect to announce the regulatory strategy we will pursue in the US for our insulin product and to receive in vivo and in vitro bioequivalence results comparing insulin produced from safflower to commercially available insulin products."