Sanofi-Pasteur is developing new vaccine formulations that need to be evaluated on their efficacy and potency. Traditionally, the use of animal models to predict human immunity has been accepted as the best way to select vaccine formulations. However, animal models can be costly and time-prohibitive, and the assays employed to assess vaccine efficacy and potency are not ideal for rapid screening and optimization of multiple formulations. To overcome these limitations, we propose to test new vaccine formulations utilizing laboratory cultured macrophage cells.

As an analytical platform, the Sanofi Pasteur Analytical Sciences (Toronto) Molecular Biology Centre (MBC) is applying and optimizing the use of high-throughput sequencing (HTS). The detection of adventitious viruses in biological products relies on a set of methods defined by the regulatory agencies called the compendial methods. High-throughput sequencing has the potential to improve the current breadth of detection and to remove some poorly performing compendial in vivo animal tests.

Since 2016, the Molecular Biology Centre has used HTS for the detection of adventitious viruses.

Vaccines are one of the most important medical breakthroughs, proactively saving millions of lifes and reducing human morbidity. Yet there remains a need to make current vaccine formulations more effective and affordable, which requires testing and optimizing new formulations. In addition, there remains diseases for which there are no efficient vaccine. To develop and test new vaccines or vaccine formulations, Sanofi Pasteur and other manufacturers often rely on animal testing.

Diphtheria is still a disease causing significant morbidity and mortality in people worldwide that did not received vaccination or suffer from incomplete immunization. The disease is due to a powerful toxin produced by the pathogenic bacterium Corynebacterium diphtheria. A good vaccine already exists but its production is rather complex and involves several steps: cultivation of the microorganism, extraction, concentration and inactivation of the toxin followed by extensive purification of the inactivated toxin (toxoid).

Vaccines are a vital part of society’s arsenal for preventing the spread of infectious diseases. Since they are challenging to produce, vaccine manufacturing is largely concentrated in select locations in the developed world. This situation presents steep obstacles to transporting them to people in the developing world who need them the most. Moreover, transportation and storage comprises roughly half the cost of a vaccine dose.

Vaccination is the most effective way to prevent influenza infections. However, the current production of influenza vaccines in embryonated chicken eggs has limited capacity during pandemics or high demand seasons, and is both labor-intensive and time-consuming. Consequently, there is a need to develop a robust production platform that can efficiently accelerate the production process and ultimately replace the egg production system. The aim of this research project is to use insect cell culture-based technology to rapidly produce virus-like particles (VLPs) as influenza vaccine candidates.

Pertussis, also known as whooping cough, is a contagious bacterial disease that targets cells in the human respiratory tract. Whooping cough is an airborne disease that causes coughing fits, difficulty breathing and potentially death. Although it can be life threatening, the disease is preventable with proper immunization. Pertactin is a commonly used protein derived from the bacterial species, B. pertussis, used in the production of the vaccine against the disease.

Multi-phase aerated stirred fermenters are well-accepted in the production of biopharmaceuticals including antibodies and vaccines. Nevertheless, their hydrodynamic and mixing characteristics as well as the influence of various process engineering variables on their performance are not fully understood. In the current study, extensive experimentation (ERT and endoscopy) and the Computational Fluid Dynamics (CFD) approach will be employed to gain deep insights into the underlying phenomena happening in aerated stirred fermenter.

The way a vaccine performs after injection is not completely understood and not all vaccines behave in the same way. To make a vaccine we must understand what is important or critical to make it work. For example a vaccine may have specific features such as its size or shape that are critical to the way the body reacts to it. When we know what these critical factors are then we make sure these are monitored and controlled as early possible in vaccine development. In this way we build quality into the product right from the start.

Manufacturing of consistently high quality products is the commitment of the pharmaceutical industry. To achieve this, new products must be thoroughly tested and the results meet government-approved product specifications. Improving existing and adopting improved analytical technologies for product testing ensure the production of safe and effective products. This is particularly critical for the manufacturing of biologic products which, relative to small molecular drugs, have a larger size, are more complex in structure and are thus more difficult to characterize.