Analysis & Qualification Service for SARS-CoV-2 Vaccine
With the emergence of new infectious diseases and new strains of current diseases (such as the novel coronavirus (SARS-CoV-2) that appeared in China at the end of 2019), the urgency of developing vaccine formulations is growing. Because vaccines are complex, expensive, and have high risks associated with their development, it is necessary to maximize the potential for rapid development of successful formulations. Creative Biolabs' vaccine development support team supports vaccine manufacturers and researchers throughout the vaccine development process, applying a comprehensive methodology to assess the quality of vaccine formulations.
Vaccine can be used not only as a prevention method of infection, but also as a therapeutic method. Vaccine development is a complex and expensive work with high risk, as most candidate vaccines fail in preclinical and first phase development. Due to the complexity of vaccine production, it is important to fully understand which factors will affect the safety, efficacy and stability of the formulation. Failure to understand the factors that may have adverse effects on vaccine formulations may lead to the selection of suboptimal conditions, even to the failure of safety, effectiveness or stability, causing project delay or cancellation. Therefore, the evaluation of vaccine quality is very important in the development of vaccine. It includes biophysical properties of antigens, assessment of stabilizers, studies of antigen-adjuvant interactions, evaluation of product contact materials (such as sterile filter membranes), and real-time and accelerated stability monitoring.
Fig.1 Components of a rational and systematic approach to the development of vaccine formulations. (Morefield, 2011)
As a new type of virus, studies of SARS-CoV-2 are not particularly comprehensive at present. Therefore, in the process of vaccine development for SARS-CoV-2, the quality control and evaluation of vaccines is a very important part.
We can start with a variety of analytical techniques for biophysical characterization of antigens. The purpose is to determine the appropriate pH, buffer type and ionic strength to prevent antigen aggregation and maintain the antigen in an appropriate folded state for early preclinical research. Following these studies, stabilizer evaluations will be performed to enhance the physical and chemical stability of the antigen. Finally, the adjuvant and its interaction with the antigen are evaluated, and the most suitable adjuvant is selected to obtain the desired immune response. All of these studies need to be supported by real-time and accelerated stability studies to verify that formulation changes during development keep the antigens chemically and physically stable. Each of these components occurs during multiple development phases and complements each other. To ensure quality and safety, we provide comprehensive quality assurance expertise to help you meet and exceed quality, safety and regulatory standards.
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