Lentiviral Vector Reference Material Project

Requests for Proposals
URGENT: RFP-2.0 Thawing, Sterile Filtering, and Vial Filling — revised April 9, 2021
RFP-3.0 Characterization — revised February 15, 2019
RFP-1.0 Vector Production and Purification — revised April 17, 2018

Accepted Proposals
Production of Lentiviral Vector Reference Material — May 31, 2018
Cell Line Testing & Storage, LVV-RM Storage (~3,000 vials) — Nov. 20, 2019

Vector Production and Purification
Status: Production is scheduled for fall 2021 Official Letter, April 9, 2021
NRC-Canada Production Specifics — March 2021
NRC-Canada Preliminary Planning — February 2019

Use and Availability
The LVV-RM is not ready yet, but most of the pieces are in place.
We still need an organization to handle the thaw/filtration/vial steps.

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

Presentations
An Overview of the LVV-RM Initiative - 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
Participant List — August 24, 2020

Contributions Received
Keith Carson, LVV-RM Executive Committee Coordinator:
Contributor Acknowledgements — March 2021

Services, products, and consumables donated — as of April 2021

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.