Production of a Broadly Neutralizing HIV Antibodies

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

Vaccine Production Program Laboratory (VPP) at the VRC is responsible for cGMP production and the manufacturing documentation needed for regulatory submission of VRC mAbs for clinical trials. To expeditiously meet the critical program needs of its Clinical Trials Program, the VRC developed a vaccine pilot plant, known as the VCMP (Vaccine Clinical Materials Program) for the manufacture of clinical materials for Phase I/II/III trials. The VPPL expanded the capability of the VCMP for the manufacture of monoclonal antibodies. The VPPL also engages in partnerships and contracts with companies in the vaccine/biotech industry for additional capacity and capability in biologicals manufacturing. The VPPL develops the manufacturing process and analytical methods needed for manufacturing mAbs, transfers the process to the VCMP for cGMP production and product release/stability testing. Such an approach enables the VRC to rapidly respond to emerging public health threats, as evidenced by the VRCs Ebola therapeutic antibody, mAb114, that was used under compassionate use protocols and studied under randomized control trials in the 2018/19 Ebola Zaire outbreak in the Democratic Republic of the Congo leading to the full FDA approval of Ridgeback Biotherapeutics Biologics License Application. for treatment of Ebola.A number of mAbs have been developed that have commercial interest (see Products or Services, below). As we proceed down the development pathway the demand for these molecules has increased requiring the development groups to further improve the manufacturing process and test methods to keep up with demand. The VPP has produced 82.5 kg of VRC01 for clinical trial use (Phase 1 studies and the AMP Phase 2 study) and Phase 1 production lots of the mAbs 10E8VLS, N6LS, CAP256LS, VRC01LS, and VRC07-523LS. Additionally, the VPP has produced master cell banks for next-gen HIV-1 mAbs VRC01v23LS and VRC01.23LS, along with completed a drug product fill of PGDM1400LS to support DAIDS.