Privately-held Ambys Medicines has announced that it has opened a 52,000-ft² facility dedicated to hepatocyte manufacturing. The facility is certified to current Good Manufacturing Practices (cGMP) regulations.
The company, based in South San Francisco, California, also presented data on its novel bioreactor manufacturing at the Joint Congress of the International Xenotransplantation Association, IXA-CTRMS-2021.
Focused on developing novel treatments of severe liver disease, Ambys says it expects its lead program to enter the clinic in early 2023.
“The concept of hepatocyte transplantation with donor cells has been explored in academic settings for over 20 years,” said Dr. Ron Park, CEO of Ambys Medicines, in a statement. “These past efforts showed that mature hepatocytes were active and that the approach was safe, but further progress has been limited by the inability to generate adequate quantities of high-quality hepatocytes sufficient to drive clinical benefit.”
Launched in 2018 with $140 million in initial funding, Ambys has received initial funding from VCs and Osaka, Japan–based Takeda (NYSE:TAK).