SemBioSys signs contract manufacturing agreement for plant-produced insulin with Cangene

27-Nov-2006

SemBioSys Genetics Inc. announced the completion of a technology transfer and Manufacturing Agreement with Cangene Corporation for the processing and purification of SemBioSys' plant-produced insulin. The contract is part of the Company's preparations for its Investigational New Drug Application (IND) and the initiation of clinical trials. Cangene will manufacture insulin for SemBioSys' preclinical and early stage clinical development.

Andrew Baum, President and CEO of SemBioSys Genetics Inc., said: "The execution of this contract is the second significant development milestone for our insulin program, following on our announcement this past July of successfully achieving commercially viable levels of insulin accumulation in safflower. We continue to advance our insulin development plan. In the near term, we expect to announce the regulatory strategy we will pursue in the U.S. for our insulin product and to receive in vivo and in vitro bioequivalence results comparing insulin produced from safflower to commercially available insulin products."

With the signing of the contract, SemBioSys intends to immediately begin work with Cangene to implement technology transfer of the manufacturing process, which shall enable 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. The contract with Cangene shall allow SemBioSys to avoid the costs associated with building and maintaining a stand-alone manufacturing facility during the early stages of clinical development.

https://www.bionity.com/en/news/59718/sembiosys-signs-contract-manufacturing-agreement-for-plant-produced-insulin-with-cangene.html