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Avid Bioservices Completes cGMP Manufacturing Suites at CGT Facility

The 53,000 sq.-ft. development and manufacturing facility will support early-stage development through commercial manufacturing.

By: Kristin Brooks

Managing Editor, Contract Pharma

Avid Bioservices, Inc., a biologics CDMO, has completed construction of cGMP manufacturing suites within its new cell and gene therapy (CGT) development and cGMP manufacturing facility as scheduled. The newly launched suites 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 purpose-built 53,000 sq.-ft. CGT development and manufacturing facility will support early-stage development through commercial manufacturing and is located in Orange County, CA, near Avid’s mammalian development and manufacturing operations. The recently completed manufacturing suites join the CGT facility’s analytical and process development labs, which were launched in 2022.  
 
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 manufacturing 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 sq.-ft. dedicated to quality control laboratory space, the facility will be fully equipped to support both clinical and commercial CGT products.
 
“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,” said Drew Brennan, general manager of viral vector technologies of Avid Bioservices.

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