PMID- 16299538
OWN - NLM
STAT- MEDLINE
DA  - 20051121
DCOM- 20051207
LR  - 20071115
IS  - 0950-9232 (Print)
IS  - 0950-9232 (Linking)
VI  - 24
IP  - 52
DP  - 2005 Nov 21
TI  - Meeting product development challenges in manufacturing clinical grade oncolytic 
      adenoviruses.
PG  - 7792-801
AB  - Oncolytic adenoviruses have been considered for use as anticancer therapy for
      decades, and numerous means of conferring tumor selectivity have been developed. 
      As with any new therapy, the trip from the laboratory bench to the clinic has
      revealed a number of significant development hurdles. Viral therapies are subject
      to specific regulations and must meet a variety of well-defined criteria for
      purity, potency, stability, and product characterization prior to their use in
      the clinic. Published regulatory guidelines, although developed specifically for 
      biotechnology-derived products, are applicable to the production of oncolytic
      adenoviruses and other cell-based products, and they should be consulted early
      during development. Most importantly, both the manufacturing process and the
      development of characterization and release assays should be science-driven, use 
      the best available science and technology, and must consider the unique nature of
      the product: a living, and mutatable, virus. Potentially significant impacts on
      product quality and safety stem from the possibility of genetic instability
      related to over-engineering the viruses (as evidenced by their recombination
      and/or occasional reversion to wild-type virus during manufacturing). This report
      provides examples of some of the critical components affecting the development
      and production of clinical grade material and summarizes the significant progress
      made in recent years.
AD  - Cell Genesys, Inc., South San Francisco, CA 94080, USA.
      peter.working@cellgenesys.com
FAU - Working, Peter K
AU  - Working PK
FAU - Lin, Andy
AU  - Lin A
FAU - Borellini, Flavia
AU  - Borellini F
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Oncogene
JT  - Oncogene
JID - 8711562
SB  - IM
MH  - Adenoviridae/*pathogenicity
MH  - Biotechnology/*methods/standards
MH  - *Genetic Engineering
MH  - Guidelines as Topic
MH  - Neoplasms/therapy/virology
MH  - *Oncolytic Virotherapy
MH  - *Oncolytic Viruses
MH  - Quality Control
MH  - Safety
RF  - 35
EDAT- 2005/11/22 09:00
MHDA- 2005/12/13 09:00
CRDT- 2005/11/22 09:00
AID - 1209045 [pii]
AID - 10.1038/sj.onc.1209045 [doi]
PST - ppublish
SO  - Oncogene. 2005 Nov 21;24(52):7792-801.