Merck + Co., Inc.

Russel Jackson Lander

Michael Albert Winters

Francis Jeremiah Meacle

David B Boyd

Jason C Murphy

Adam Joel Kristopeit

Methods of isolating clinical-grade plasmid DNA from manufacturing processes, including large-scale fermentation regimes, are disclosed which encompass alternatives to two core unit operations common to plasmid DNA purification processes. The novel upstream and downstream purification processes disclosed herein provide for reduced production costs and increase process robustness. Either or both of the purification processes disclosed herein may be used in combination with additional purification steps known in the art that are associated with DNA plasmid purification technology.

Purification process for plasmid DNA

The present invention relates to a nonchromatographic-based process for the isolation of clinical grade plasmid DNA from bacterial cells. The exemplified methods described herein outline a scaleable, economically favorable protocol for the purification of clinical grade plasmid DNA fromwhich includes CTAB-based precipitation of DNA in combination with adsorption of impurities to calcium silicate.

Process for the scaleable purification of plasmid DNA

The present invention relates to a nonchromatographic-based process for the isolation of clinical grade plasmid DNA from bacterial cells. The exemplified methods described herein outline a scaleable, economically favorable protocol for the purification of clinical grade plasmid DNA from which includes CTAB-based precipitation of DNA in combination with adsorption of impurities to calcium silicate.

Bacterial polysaccharides which are used to produced vaccines are isolated then precipitated with a long chain detergent. The precipitated polysaccharides are soluble in organic solvents and can be further derivatized and processed to form the vaccine.

Growing community of inventors

Lansdale, PA, United States of America

Russel Jackson Lander