Aldevron Breakthrough Blog

James Brown, Ph.D., Presenting "Standardized Plasmids for Viral Vector Production" Tech Talk at American Society of Gene & Cell Therapy Annual Meeting

Representatives from Aldevron will attend the 22nd Annual Meeting for the American Society of Gene & Cell Therapy (ASGCT), April 29 - May 2, 2019, in Washington, D.C.

james-brown-aldevronThe program will consist of oral and poster presentations on the latest research, data and information in fields that contribute to advancing gene and cell therapies. Nearly 1,000 abstracts were published in the Clinical Trials Spotlight in Molecular Therapy (Vol 27, No 4S1). Aldevron’s James Brown, VP Corporate Development, is speaking on standardized plasmids for viral vector production as well as presenting a poster. An abstract of the research is included below.

“We are pleased to present our data at the ASGCT annual meeting,” said Brown. “Our results demonstrate the ability to manufacture plasmid DNA at 300 L scale and show that standardized plasmids can be used for viral vector production. These results combine to make standardized plasmids an attractive alternative to custom manufacturing. The immediate availability, lower cost, and freedom to operate of these products enable a faster and more economical path for gene therapy product development.”

735. Advantages of Standardization and Large-Scale Manufacturing of Helper Plasmids for Viral Vector Production

Cody Grasswick1, Robert Reames1, Luise-Elektra Keller2, Emma Page2, Qian Liu2, Janelle Muranaka3, Meagan Gelinske1, Nate Spangler1, James Brown1, Robert Whalen3, Henry Hebel1, John Ballantyne1, Michael Chambers1

1-Aldevron, Fargo, ND, 2-Oxford Genetics, Oxford, United Kingdom, 3-Maxygen, Sunnyvale, CA

Success in gene and cell therapy has increased demand for plasmid DNA used to produce viral vectors, both in quantities for commercial products as well as the breadth of different vectors for the expanding number of programs in development. Our data and analysis indicate that standardization and large-scale production of helper plasmids, those that are the same regardless of the specific viral vector produced, represents an opportunity to significantly reduce timeline, cost, and risk. We have developed processes to quickly produce a set of helper plasmids that consistently generate high-titer viral vectors, are immediately available for research and clinical production, and are free of any royalties or future payments. To meet production scale requirements, our technical operations team has developed and deployed a platform based around a single-use, 300-liter fermentation device and process train capable of purifying up to 100 grams of a plasmid in a single processing event. The manufacture of the output from an individual fermentation process can take as little as seven days. Scaling work done in the early engineering phase for this train was integral to the design of a new 70,000 square foot manufacturing plant. Our data show that fermentation scalability can support large processing events and the production of optimized helper plasmids can enable high-titer lentiviral vector production. Standardization of lentiviral plasmids supports consistency and efficiency at large scale and across multiple programs. Our data show the scalability of fermentation for a typical plasmid at 30 L and 300 L, with specific yield maintained as scale is increased. Our data also show the performance of lentiviral vectors produced with optimized plasmids, indicating improved performance over other plasmid systems. The availability, cost, freedom to operate, and consistency of these plasmids will help address the growing demands of cell and gene therapy.

About Aldevron

Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-SourceTM quality system. Company headquarters are in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Freiburg, Germany.

Topics: Events, Plasmid DNA, Viral Vector Therapeutics