This five-day short course is designed to give participants a broad understanding of viral vaccine production. Participants will be introduced to vaccine fundamentals, including virus types, virus structure and basic vaccine immunology, followed by the steps necessary to produce, recover and purify virus, using influenza A as a model. The course uses a combination of lecture and hands-on laboratory activities, allowing participants learn the fundamentals of egg-based and cell-based virus production; virus recovery and purification methods including ultracentrifugation, chromatography, and ultrafiltration. Basic analytical techniques for quantifying and characterizing virus are also examined. At the end of the course, attendees will have a thorough understanding of the “how and why” behind vaccine manufacture and consequently be better equipped to manufacture viral vaccines and troubleshoot vaccine processes.
The Biomedical Advanced Research and Development Authority (BARDA) funded a five year program to provide a series of short courses focused on influenza vaccine techniques for international vaccine manufacturers. As part of this program The Golden LEAF Biomanufacturing Training and Education Center (BTEC) at NC State, has developed 3 course.
Fundamentals of cGMP Influenza Vaccine Manufacturing
The fundamental cGMP course is a 3 week short course that provides participants with an overview of all steps of the influenza vaccine production process (Cell culture and egg culture systems, Upstream processing, Aseptic practices, Facilities and design, Downstream processing, Analytical, and Regulatory). Through a combination of classroom lecture and hands-on laboratory exercises participants will gain an participation for the entire production process.
Advanced Upstream Processes for Influenza Vaccine Manufacturing
The advanced upstream course is a 2 week short course that provides participants with in-depth hands-on laboratory exercises focused on upstream process develop. Over the course of the 2 weeks participants work with cell culture and egg culture platforms side by side at both the small scale (25-50ml) and intermediate scale (3-5L). By the end of this course students will have a better understanding of the strengths and weaknesses of these two platforms and the technologies available for each.
Advanced Downstream Processes for Influenza Vaccine Manufacturing
The advanced downstream course is a 2 week short course that focuses on designing steps for the recovery and purification of influenza vaccine. Lectures focus on selection of unit operations for an influenza vaccine process, key process and performance parameters for downstream unit operations, methodologies for specifying ranges for these parameters, and basic guidelines for scaling-up process steps. Lab exercises build on lecture material by providing hands-on exercises focused on comparing performance of different unit operations (e.g., ultracentrifugation vs. chromatography), specifying process parameter ranges, and determining parameter values required for scale up.