OrganaBio, a provider of MSCs, HSCs, and immune cells for cell and gene therapy developers, started construction on its current Good Manufacturing Practices manufacturing facility for cell and gene therapy manufacturing in Miami, Florida.
Phase I of the cGMP manufacturing facility is slated to open the third quarter of 2021 and will include process development space, 1-2 ISO7 cleanrooms, a QC laboratory and support spaces. The OrganaBio portfolio of cGMP cell products is subsequently slated to launch in the fourth quarter of 2021.
“OrganaBio’s mission is to supply cell and gene therapy companies with mission-critical, but hard to procure resources that are needed to advance therapeutic programs,” said Justin Irizarry, CEO of OrganaBio. “We are addressing broad supply chain challenges through an innovative portfolio of products and services that offer both pre-clinical and cGMP solutions for our customers.” Without clinical grade starting materials and an accessible manufacturing solution, therapeutic developers cannot advance their program into a clinical phase.”
Michael A. Finney, President & CEO, the Miami-Dade Beacon Council, noted, “We are excited about OrganaBio’s cGMP 19,000 square foot manufacturing facility which is set to create a large amount of lab space in the County that, in turn, will continue to grow Miami’s life sciences ecosystem.”
The company said its manufacturing solution will offer ready access to its portfolio of birth tissue- and adult tissue-derived cellular starting materials and expertise in cGMP manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs to its customers and partners. These resources will accelerate each therapeutics developer’s path to clinical translation and commercialization.
“Miami is already home to several universities actively participating in biomedical research, and OrganaBio’s new cGMP lab space will foster continued academic and commercial innovation,” Finney added.