The purpose of this volume of Methods in Molecular Medicine is to set
forth examples of the great variety of techniques and applications that
are now emerging in the field of nonviral gene therapy. The book
emphasizes not only specific approaches to gene delivery but, in
particular, the best current me- ods to prepare, handle, and
characterize gene delivery agents. These topics are of very broad
importance since gene therapy evolves from its mostly ac- emy-based
experimental and clinical research to the ever increasing number of
industry-driven programs directed toward commercial development. S-
cessful introduction of nonviral gene therapy agents into the clinic
should be expected to require rigorous manufacturing and analytical
methods that readily meet the regulatory guidelines under which new drug
candidates are reviewed for marketing approval. Exactly what those
guidelines will prove to be c- tainly depends on the established
guidelines for review of both biological and chemical therapeutics.
Additionally, many new techniques are being devised and applied to gene
therapy research; these techniques will be instrumental in developing
and characterizing successful gene delivery agents. Nonviral Vectors for
Gene Therapy: Methods and Protocols has two main sections. To start
with, there is a series of chapters on specific protocols for the
synthesis, characterization, and application of gene delivery agents. S-
eral chapters address the topic of materials to bind with DNA to form
the compact condensed phases that facilitate cellular delivery.
