# GMP Production of Envelope Immunogens

> **NIH NIH U19** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $7,311,966

## Abstract

Project 3 is an integral part of our IPCAVD Program grant. We propose to produce cGMP grade Env
immunogens (two) that will be evaluated clinically in a Phase I trial by the HIV Vaccine Trials Network. Our
commerical partner in the GMP-production of our Env immunogens is ABL, Inc. (ABL). We developed a plan
that ensures the most efficient transfer of materials and 'know how' In Env expression, purification and
characterization (antigenicaily and immunogenically) from the Stamatatos lab to ABL. The Stamatatos lab
and ABL will be In continuous communication to ensure the rapid resolution of any issues that may arise.
The Stamatatos lab will verify and ensure that all Env-related products (intermediate and final) generated by
ABL meet the required antigenic and immunogenic criteria our immunogens must meet before their clinical
testing.The proposed strategy for the production of Env immunogens is based on the expertise of the
Stamatatos lab in Env expression, purificaiton and characterization with ABL's expertise in large scale GMP
manufacturing of proteins/drugs, including recombinant Env proteins.

## Key facts

- **NIH application ID:** 9927554
- **Project number:** 5U19AI109632-08
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Leonidas Stamatatos
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $7,311,966
- **Award type:** 5
- **Project period:** — → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9927554

## Citation

> US National Institutes of Health, RePORTER application 9927554, GMP Production of Envelope Immunogens (5U19AI109632-08). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9927554. Licensed CC0.

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