Current initiates for vector standards

Note: for the purposes of this exercise, we have not considered ‘guidelines’ as standards, because they are intentionally flexible.  This means only physical reference materials are identified, no formal written standards were identified.

AAV

ATCC: Recombinant Adeno-associated virus 8 (VR-1816™)

• The adenovirus reference standard materials can be used in the calibration of vector standards within individual laboratories and improve preclinical and clinical data comparisons using common dosages.

ATCC: Recombinant Adeno-associated virus 2 (VR-1616™)

• Use as reference material in gene therapy research. Publication: Characterization of a recombinant adeno-associated virus type 2 Reference Standard Material. (2010)

Vigene Biosciences: AAV Reference Materials

• AAV reference materials (user manual, commercially available)
  AAV1, AAV2, AAV5, AAV6, AAV8, AAV9 Empty & Full Capsids
  Also available from amsbio
  Publication: Standardized AAV manufacturing: Why are AAV reference materials needed?
  NIST/NIIMBL/USP: assess analytical methods and develop standards for adeno-associated virus (AAV)
  NIBSC: Physical Standards for Adeno-associated virus (AAV) Gene Therapy (Grant) will involve preparing an initial reference batch of a gene therapy vector based on the Adeno-associated virus (AAV) virus.

Adenovirus

ATCC: Human adenovirus 5 (VR-1516™)

• The Ad5-RM Working Group is currently working with ATCC, the National Institute of Standards and Technology, and industry partners to produce more of this material.
  Publication: Manufacturing and characterization of a recombinant adeno-associated virus type 8 reference standard material (2014)
  See ISBioTech – stocks low, planning to make more.

ISBioTech: Adenovirus Reference Material Project