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. However, the inventory has been depleted and we are working with ATCC, FDA/CBER, and NIST to make more of this material (see below for more information).
Lentiviral Vector Reference Material Project
Status: In Progress with production and purification completed in February 2023. Material is being shipped to ATCC where it will be sterile filtered, vialed, tested, stored, and distributed sometime this summer, 2023.
Adenoviral, Serotype 5, Reference Material Project
Status: Inventory Has Been Depleted. We are working with ATCC, FDA/CBER, and NIST to make more of this material, which we believe will be available in the Summer of 2023.
Adeno-Associated Virus Project
Status: Available — AAV2 Documentation — AAV8 Documentations
Baculovirus Project
Status: List of Participants
Porcine Endogenous Retrovirus Project
Status: List of Participants
Retrovirus & Lentivirus 2002 Project
Status: Project Ended