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.
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 below.
The DHVI current Good Manufacturing Practices (cGMP) Facility consists of five manufacturing suites featuring state of-the-art single-use equipment for the manufacture of antigens, mRNA therapies and vaccines, and other cell or bacterial-based products as required. The manufacturing capability is complimented by dedicated teams for cell line development, process development, analytical development and quality control, program management, quality assurance and regulatory teams. The facility is led by Dr. Matthew Johnson and managed under a quality system to ensure that that all GMP requirements are met for the manufacture and release of clinical products.
The DHVI Protein Production Facility (PPF) is a Core service center Directed by James Peacock, PhD. The Facility makes recombinant proteins to support CIVICS investigators. Specifically, the facility is equipped to produce and purify, at cost, HA proteins and antibodies as standardized reagents that can be used in influenza vaccine research. These reagents are intended for basic research, clinical trial immune monitoring assays and to facilitate immunogen discovery in small animal models. Proteins are not intended for use in humans or in clinical trials.