FDA statement regarding the use of adeno-associated virus reference standard materials

Human Gene Therapy Methods

Volumn 26, Issue 1, 2015, Pages 3-

  Gavin, Denise K ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PARVOVIRUS VECTOR;

ADENO ASSOCIATED VIRUS; ASSAY; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; LETTER; PRIORITY JOURNAL; PRODUCT SAFETY; RELEASE ASSAY; STANDARD; ADVERSE EFFECTS; DEPENDOPARVOVIRUS; GENE VECTOR; GENETICS; LEGISLATION AND JURISPRUDENCE; STANDARDS; UNITED STATES;

ADENO-ASSOCIATED VIRUS;

DEPENDOVIRUS; GENETIC THERAPY; GENETIC VECTORS; REFERENCE STANDARDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84923224285     PISSN: 19466536     EISSN: 19466544     Source Type: Journal    
DOI: 10.1089/hgtb.2015.1501     Document Type: Letter

References (2)

1. Ayuso E, Blouin V, Lock M, et al. Manufacturing and characterization of a recombinant adeno-Associated virus type 8 reference standard material. Hum Gene Ther 2014; 25: 977-987
2. Lock M, Mcgorray S, Auricchio A, et al. Characterization of a recombinant adeno-Associated virus type 2 reference standard material. Hum Gene Ther 2010; 21: 1273-1285