OrganaBio has begun construction on its current Good Manufacturing Practices (cGMP) manufacturing facility for cell and gene therapy manufacturing.
A Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials.
“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,” Justin Irizarry, CEO of OrganaBio, said in a statement. “We are addressing broad supply chain challenges through an innovative portfolio of products and services that offer both preclinical 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.”
The company has partnered with Flad Architects and DPR Construction, leading Life Sciences architecture and construction firms, respectively, to design and build the facility, housed in a brand-new commercial business park, just 10 miles north of the Miami International Airport.
“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,” said Michael A. Finney, President & CEO, the Miami-Dade Beacon Council. “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.”
OrganaBio’s 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. Phase I of the cGMP manufacturing facility is slated to open Q3 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 Q4 2021.