Julie E. Ledgerwood, D.O.

Julie E. Ledgerwood, D.O.

Credit: NIAID
Acting Chief, Vaccine Production Program Laboratory

Major Areas of Research

  • Process design and development
  • Regulatory strategy
  • Translational program management

View all research conducted at the Vaccine Research Center (VRC)

Program Description

The goal of the Vaccine Production Program Laboratory (VPPL) is to efficiently translate candidate research vaccines into materials for proof-of-concept clinical trials and to enable advanced development and licensure by partners. The VPPL is responsible for process design and development, clinical good manufacturing practices (cGMP) manufacturing, pre-clinical safety testing, and regulatory activities for all VRC products. Since its inception in 2001, the VPPL has overseen the manufacture of over 68 bulk pharmaceutical compounds formulated into 40 different vaccine and therapeutic products. These products include candidate vaccines for HIV, influenza, filoviruses including Ebola and Marburg, and alphaviruses including chikungunya, SARS, and West Nile.

The laboratory includes development groups for stable cell line generation, cell culture (upstream), purification (downstream), formulation, and analytical testing (characterization and lot release). The focus is on developing state-of-the-art production methodology that will support both the cGMP manufacturing of material for VRC clinical trials and the effective transfer of successful candidates to partner organizations for eventual commercialization. Flexibility is essential as candidate formats include DNA plasmids, viral vectors, recombinant antibodies and other proteins, virus-like particles, and self-assembling nanoparticles.

Once a process is developed, it is transferred to the Vaccine Pilot Plant (VPP), located in Frederick, Maryland, for cGMP production. The VPP, completed in 2005, has four independent production trains in a facility of 126,900 square feet. Two trains operate at 100 liter scale, one train at 400 liter scale, and one train at 2,000 liter scale. There are also suites for inoculum preparation and for media/buffer preparation. The filling operations are qualified to perform small-scale lots up to 5,000 vials and large-scale lots up to 15,000 vials. The warehouse is sized to handle raw materials and supplies sufficient to maintain production operations with coordination and control through the adjacent dispensary. Quality control laboratories and a quality assurance department are responsible for oversight of cGMP manufacture including validation, compliance, lot release, and document control. The VPP is operated under contract by Leidos Biomedical Research, Inc. at the Frederick National Lab.

The Regulatory Science Group within the VPPL is responsible for setting regulatory strategy and for managing regulatory activities for all VRC products. The regulatory group has assembled more than twenty investigational new drugs (INDs) and master files since 2001. The group also leads the development and performance of good laboratory practices (GLP) safety studies for planned clinical products. The Translational Program Management Group of the VPPL is responsible for the cross-VRC coordination of VRC projects and programs. The VPPL establishes Collaborative Research and Development Agreements (CRADAs) with industry partners to bring innovative vaccine technologies in for development or to continue development of VRC candidates beyond Phase I or II clinical development.

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