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.