Statistical Analysis and Modeling of Vaccine Manufacturing Process Applied to Cell-Culture Based Adenovirus Vaccine

This project intends to research vaccine manufacturing process from a broader perspective and apply Quality by Design (QbD) concepts to develop a robust novel process for commercial vaccine production. To implement QbD principles, the impact of several process parameters (including cell density, pH, temperature, and harvest time) on the Critical Quality Attributes (CQAs) of the vaccine product (including yield, potency, and purity) will be revealed using statistical process analytical technologies such as Profiling, Principal Component Analysis, and Monte Carlo simulations. Statistical models will be developed, accounting for potential co-dependencies among the CQAs. The method will be established from data on cell-culture based Adenovirus as a vector for antigen delivery, generated in collaboration with other researchers. Subsequently, experiments will be designed and statistical analysis and modeling will be completed based on the new results. The methodology enables the industrial partner to establish QbD concepts for a range of vaccine manufacturing processes.

Faculty Supervisor:

Amine Kamen

Student:

Bahareh Golfar

Partner:

PnuVax SL Biopharmaceuticals Inc.

Discipline:

Engineering - chemical / biological

Sector:

Pharmaceuticals

University:

McGill University