Good manufacturing practice production of adenoviral vectors for clinical trials.
The increasing importance of recombinant adenoviral vectors for gene therapy, cancer therapy, and the development of prophylactic and therapeutic vaccines has led to worldwide efforts toward scalable process development suitable for commercial manufacturing of replication-deficient adenoviral vectors. This review focuses on the manufacturing of adenovirus for clinical trials in the context of good manufacturing practice conditions and regulations.
Lusky
Monika
M
Transgene, 67082 Strasbourg, France. lusky@transgene.fr
D000256:Adenoviridae / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D015316:Genetic Therapy / Q000379:methods*; D005822:Genetic Vectors / Q000235:genetics*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards*; D014765:Viral Vaccines / Q000235:genetics; D014776:Virus Cultivation / Q000295:instrumentation / Q000379:methods*
D014765:Viral Vaccines