BioHarvest Sciences Inc. (NASDAQ: BHST) announced that its proprietary Olive Cell composition has reached commercial readiness and is available for licensing through its contract development and manufacturing organization (CDMO) business.

The milestone covers completion of plant-cell development, large-scale bioreactor scale-up, commercial manufacturing validation at the company's GMP facility, and a self-affirmed U.S. Generally Recognized as Safe (GRAS) process for applicable intended uses. The self-affirmed GRAS conclusion does not constitute FDA approval.

Derived from Olea europaea fruit, the Olive Cell composition is a standardized olive fruit cell powder whose primary polyphenol is Verbascoside, a hydroxytyrosol derivative. The company states the composition delivers Verbascoside at higher and more consistent concentrations than natural olive fruit or conventional extracts.

BioHarvest previously reported preliminary in-vitro findings in which Olive Cell reduced intracellular lipid accumulation by up to 37% in an oleic-acid-induced steatosis model using HepG2 human liver cells, and reduced collagen type I accumulation by up to 50% in a TGF-β1-induced fibrosis model using LX-2 hepatic stellate cells. The company notes these results do not establish efficacy in humans and that further studies are needed.

"The asset is now ready to license, and our GMP manufacturing facility is ready to produce it for the right customer," said Dr. Zaki Rakib, Chief Executive Officer and Executive Chairman of BioHarvest Sciences.

Olive Cell follows VINIA, the company's first commercialized plant cell compound derived from red grapes, as a second distinct composition to complete development, large-scale manufacturing, and the applicable U.S. self-affirmed GRAS process. BioHarvest said it intends to pursue licensing, manufacturing, royalties, co-development, and ownership participation arrangements for the asset.

Information in this article is based on a company press release statement.