Lentiviral Vector Reference Material Project

Requests for Proposal
RFP-1.0 Vector Production and Purification — revised April 17, 2018
RFP-2.0 Sterile Filtration, Vialing, and Repository Service — revised November 21, 2018
RFP-3.0 Characterization — revised February 15, 2019

Accepted Proposals
Lentiviral Vector Sterile Filtration, Vialing, and Storage — revised December 28, 2018
Lentiviral Vector Production — revised May 31, 2018 and Project Update — revised February 2019

Use and Availability
The project is currently in hiatus due to COVID-19. Please check back soon.

Project Documentation
Meeting Minutes - Washington, DC: March 10, 2015
Meeting Minutes - Washington, DC: March 8, 2016
Meeting Minutes - Washington, DC: March 7, 2017
Meeting Minutes - Norfolk, Virginia: March 6, 2018
Meeting Minutes - Norfolk, Virginia: March 5, 2019

Presentations
Presentation - Washington, DC: March 7, 2017

References & Related Articles
Scalable Lentiviral Vector Production Using Stable HEK293SF Producer Cell Lines

Inducible Packaging Cells for Large-Scale Production of Lentiviral Vectors
in Serum-Free Suspension Culture


Lentivirus Working Group Participants
Participants as of August 24, 2020

Contributors
We would like to express our sincere appreciation for the consumable products and testing services these fine organizations have donated to the Lentiviral Vector Reference Material Project (LVV-RM). This reference material will be used by organizations that are developing lentiviruses for use in gene and cellular therapies to help qualify, or validate, their internal reference material and assays. Data developed and compared to the LVV-RM will provide tremendous value to the organization developing a product, as well as FDA CBER, which can use the LVV-RM to compare product submissions.