Articles on disposables: implementation, validation, cost-benefit analysis - BioPharm International

ADVERTISEMENT

Disposables
The advantages and disadvantages of disposables, along with cost-benefit analyses, validation strategies, and implementation approaches.

Disposable Process for cGMP Manufacture of Plasmid DNA

November 2, 2007

Disposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.

ADVERTISEMENT

ADVERTISEMENT

Click here