Application Note

Production Of Therapeutic Plasmid DNA In Single-Use Fermentors

By Jason Brown, Juozas Šiurkus, Dmitrij Bugajev and Nephi Jones, Thermo Fisher Scientific

The manufacturing of plasmid DNA is becoming a supply bottleneck due to rapidly growing demand for various gene-targeting biotherapeutics. Many producers and end users are moving towards expanding or implementing single-use production facilities to efficiently meet the demand. Here we will review three procedures for production of therapeutic plasmid DNA in Thermo Scientific™ HyPerforma™ Single-Use Fermentors (S.U.F.s) at 6—30 L working volumes. With all three procedures, equivalent yields per gram of cell paste were achieved in comparison to heat-sterilized vessels.

Modern S.U.F. technologies enable production facilities to achieve equivalent yields in the same time frame (or better) as traditional stainless steel fermentor vessels. Typically, vessel setup time and startup costs are significantly less, as the S.U.F. hardware requires less stainless steel for manufacture and no clean-in-place (CIP) skid, steam equipment, or validation process. Each single-use Thermo Scientific™ BioProcess Container (BPC) ships sterile and validated, reducing downtime between cultures and allowing for greater production volume in less space. With 6—300 L working volumes, the S.U.F.s provide a closed system that eliminates the chance of cross-contamination while providing rapid scale-up for therapeutic plasmid DNA production.

access the Application Note!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Pharmaceutical Online