Reference Materials

ISBioTech has played a major role in the production of viral reference materials that can be used to qualify, or validate, internal reference materials and assays. Such reference materials can be extremely valuable to the organizations using them, and can provide regulators with the ability to more readily compare viral product submissions.

Adenovirus serotype 5 (Ad5) was produced in 2001 when all viral vector development was halted due to a lack of control on patient dosing. Today, this material is still used worldwide, and remains stable and sterile as determined by testing that is done every two years. Today, ISBioTech is helping to develop a Lentiviral Vector Reference Material, which should be available in 2021.

Lentiviral Vector Reference Material Project
Adenoviral Reference Material Project
Adeno-Associated Virus Project
Baculovirus Project
Porcine Endogenous Retrovirus Project
Retrovirus & Lentivirus 2002 Project