Work

Adventitious Mutations in Clinical Grade Vectors: An Issue to Consider?

Year: 2006

Type: article

Abstract: New viral vectors in development for clinical trials typically undergo extensive preclinical testing of their identity, efficacy and safety. For large viruses, such as those derived from Herpes simplex virus (HSV)-1, sequencing of the entire genome is thought to be somewhat prohibitive. Instead, restriction mapping combined with sequencing of the intentionally manipulated regions has usually been considered sufficient to confirm identity of the recombinant virus. Formal toxicology studies of the final GMP product are also required to support an application for an Investigational New Drug.

Source: Molecular Therapy

DOI: 10.1016/j.ymthe.2005.03.040

Authors: David A. Williams, Timothy P. Cripe

Institutions: Cincinnati Children's Hospital Medical Center, University of Cincinnati

Language: English

Topic: Virus-based gene therapy research

Subfield: Genetics

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,500