Viral Reference Materials

For nearly 25 years, the organizations led by Keith L. Carson, ChE, MBA, have 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). 

Lentivirus Vector Reference Material (LVV-RM) Project

Status: In Progress. Production and purification was completed in February 2023.  Material has been shipped to ATCC where it is in the process of being sterile filtered, vialed, tested, and stored. It will be available for distribution in the coming months.

Adenovirus Serotype 5 Reference Material (Ad5-RM) 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 made available in the second half of 2024.

Adeno-Associated Virus Reference Material (AAV-RM)Project

Status: AvailableAAV2 DocumentationAAV8 Documentations

Baculovirus Reference Material Project

Status: Project Ended. List of Participants

Porcine Endogenous Retrovirus Reference Material Project

Status: Project Ended. List of Participants

Retrovirus & Lentivirus 2002 Reference Material Project

Status: Project Ended. List of Participants