Duke Vaccine Manufacturing and Toxicology Core

About

The Duke Human Vaccine Institute (DHVI) commissioned a manufacturing facility for HIV vaccine development in 2016; soon thereafter, the manufacturing facility began onboarding influenza vaccine and therapeutic platforms. This facility hosts the CIVICs Vaccine Manufacturing and Toxicology Core, which follows Good Manufacturing Practices (GMP) to ensure patient safety and product quality. The Core’s GMP Program is designed to meet the demand for fast, iterative, early-phase process development and clinical manufacturing as an enabler for research organizations. The Core uses flexible, non-fixed equipment, to enable rapid layout configuration changes that keep pace with the shifting needs of the manufacturing facility. Additionally, the team uses single-use, closed system unit operations in manufacturing. The GMP team includes experts in the field with extensive experience in industry before joining the DHVI and works collaboratively with third party entities routinely for toxicology studies and has its own regulatory office of Investigational New Drug (IND) and Investigator’s Brochure (IB) submissions.

Dr. Matt Johnson, Dr. Tony Moody, Principal Investigator, Duke Vaccine Manufacturing and Toxicology Core

Principal Investigator

SR. DIRECTOR PRODUCT DEVELOPMENT

Duke Human Vaccine Institute (DHVI)

Investigators

Duke University

  • Tom Denny, MSc, Professor, Department of Medicine, Duke Human Vaccine Institute

Other Key Personnel

Program Managers

  • Chris Todd, MPH, Director of Program Administration, Duke Human Vaccine Institute
  • Andrea Pappas, PhD, Program Manager, Duke Human Vaccine Institute
  • Cherell Harris, JD, DGP Portfolio Manager, Duke Human Vaccine Institute

Other Staff

  • Seth Thomas, PhD, Associate Director, Process Development, Duke Human Vaccine Institute
  • Amy Caparoni, MS, Associate Director, DGP Operations, Duke Human Vaccine Institute
  • James Peacock, PhD, Head of Cell Line Development, Duke Human Vaccine Institute
  • Diana Martik, PhD, Head of DGP Analytics, Duke Human Vaccine Institute
  • Daniel Ozaki, MPH, DGP Quality Manager, Duke Human Vaccine Institute
  • Daniel Tonkin, PhD, Regulatory Affairs Scientist, Duke Human Vaccine Institute
  • Maureen Maughan, PhD, Senior Project Leader, Duke Human Vaccine Institute

Good manufacturing practices (GMP) are standard practices that are set by agencies that authorize and regulate industries that manufacture and sell foods, drugs and medical devices.  GMP practices ensure that the vaccines created by CIVICs are safe for human trials. The Duke Vaccine Manufacturing and Toxicology Core has a state of the art GMP Facility, which can be virtually toured here.