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news.Medgenics, a developer of the novel Biopump technology, has opened first US Biopump processing facility in Davis, California.
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The company’s contract manufacturing organization is currently processing Epodure Biopumps for the treatment of anemia in a good manufacturing practice certified facility.
Medgenics president and chief executive officer Andrew Pearlman said the initial processing of Biopumps in the GMP facility of US CMO resulted in product that meets all quality requirements for use in human clinical trials.
"We plan to continue with processing additional lots of product to ensure consistency and reliability before the U.S. clinical trial commences," Pearlman said.
The first Biopump processing site outside of Israel provides Medgenics with an ability to scale-up its clinical and commercial capabilities to address global therapeutic areas such as anemia and hemophilia, according to the company.
The tissue micro-organs were obtained in a key dry run test of the production system and loaded into individual closed processing chambers in Israel, and latter shipped to the US CMO Biopump processing center in California.
The micro-organs were then processed in their closed systems into Epodure Biopumps, meeting the release criteria for use in human clinical trials in the US.