The 25,000-square-foot facility will include process and analytical laboratories, cGMP manufacturing cleanrooms and support areas, quality control laboratories, a warehouse, and office space. These will join existing process and analytic development operations and laboratory space.
The new facility is expected to be completed by the end of the year, at which point Pack Gene’s Houston-area workforce will triple to around 60 employees.
The company broke ground on the full-service operations center last week to support a growing base of US customers advancing gene therapy programs. The event was attended by Paul Li, founder and president of PackGene; Betty Russo, Gulf Coast / East Texas regional representative, Office of the Governor, State of Texas; and Ann Tanabe, CEO, BioHouston, Inc.
Working with gene therapy programs from R&D to IND
"We are excited to bring economical, reliable, and scalable AAV products, as well as our viral vector development and GMP production capabilities, to our next full-service operations center in Houston," said PackGene Chief Technology Officer LiYing Yang.
PackGene’s proprietary π-Alpha 293 AAV High-Yield Platform uses uniquely designed RC plasmid in the triple-plasmid transfection system to increase AAV production by three to eight times in various AAV serotypes.
By combining both in-process upstream and downstream QbD optimizations, the total AAV yield can be increased up to ten times, according to the company.
PackGene's services are based on major technology platforms including the π-Alpha 293 cell AAV high-yield platform and π-Omega plasmid high-yield platform, with comprehensive analytical development and quality control capabilities.
"These capabilities will enable us to serve our US customers better and, importantly, to help bring life-saving therapies to patients faster, more reliably, and more cost- effectively.
"With this, we are making great strides in advancing our mission of 'making gene therapy affordable'."
Founded in Massachusetts, US, PackGene has additional operations in Guangzhou, Shanghai, and Boston.
The company works with customers to support gene therapy programs from early-stage research & development and preclinical development to IND-enabling (Investigational New Drug) studies.
PackGene aims to accelerate gene therapy product development by providing a fully integrated one-stop solution including plasmid, viral vector, fill-finish, and quality control analytical services for the gene therapy industry.