The newly launched CGMP manufacturing suites, located in Orange County, California, are currently undergoing final environmental monitoring and performance qualification.
With the completion of this latest and final expansion project, Avid estimates that its combined facilities now have a potential total revenue generating capacity of up to approximately $400 million annually.
The 53,000 square foot CGT development and manufacturing facility will support early-stage development through commercial manufacturing and is located just five miles from Avid’s mammalian development and manufacturing operations.
The new manufacturing suites join the CGT facility’s analytical and process development labs, which were launched in 2022.
Nick Green, president and chief executive officer of Avid Bioservices, said: “Over the past few years, we have implemented a strategic expansion plan designed to grow both our capacity and capabilities to align with the demands of the evolving biopharmaceutical market. With the completion of our CGT facility and launch of its CGMP manufacturing suites, we have now completed all phases of that expansion plan and find ourselves strongly positioned to meet the needs of our current and future customers.
“The completion of this expansion is another example of the Avid team’s ability to execute. The facility’s completion comes only 24 months after we first broke ground and, when allied with the other activities and expansions undertaken by the team during this period, represents a significant achievement. We look forward to engaging with customers and offering them the full range of capabilities necessary to serve their needs along with Avid’s significant experience of operating CGMP-compliant facilities.”
Avid’s CGT facility will have the capability to produce suspension culture batches of up to 3,000 liters, as well as adherent cultures utilizing fixed bed bioreactors.
Additionally, the suites are designed to produce drug product with the use of state-of-the-art filling and capping machinery performed under isolator. With over 6,000 square feet dedicated to quality control laboratory space, the facility will be fully equipped to support both clinical and commercial CGT products.
Drew Brennan, general manager of viral vector technologies of Avid Bioservices, commented: “As more and more clinical successes are achieved in the cell and gene therapy space, we will continue to see increasing demand for CDMOs with extensive commercial manufacturing experience and mature, well-tested quality systems. Avid Bioservices is very well positioned through our new CGT facility and experienced team to produce these life-saving therapies for the benefit of patients around the world.”
Avid plans to commemorate the completion of the CGT facility by hosting a celebratory grand opening in January 2024.
