820. Cost-Effective, Pharmaceutical-Grade Plasmid Production Method for Commercial Use

Autor: Hugo Gonzalez, Henry Hebel, Sriram Ramakrishnan, Heather Attra
Rok vydání: 2004
Předmět:
Zdroj: Molecular Therapy. 9:S310-S311
ISSN: 1525-0016
Popis: Cost-effective production of commercial-scale batches of pharmaceutical-grade plasmid DNA remains a challenge for the maturing industry of plasmid-based biologics. A process is required that meets the quality standards for human pharmaceutical products and yet is economically suitable for use in veterinary medicine or as an in-process product for viral therapeutic production. Previously described scaleable cell lysis requires a substantial capital investment. Also, these techniques contaminate the process stream with unnecessary impurity levels. A simple, effective purification strategy requires elimination of all animal-derived enzymes, without adding costly column-based chromatography steps. The method described herein has produced multi-gram batches of pharmaceutical-grade plasmid at a fraction of the cost of previously described methods.
Databáze: OpenAIRE