Throughout the manufacturing process for vaccines an assortment of microbial QC assays must be performed to confirm that microbial contaminants are maintained within appropriate limits
A recent article in Bloomberg highlights some of the challenges faced by manufacturers trying to respond to this year’s flu vaccine issues, noting that vaccine production is an '80 year old process now used to inoculate the population'. The article identifies the areas of production and distribution as two opportunities for improvement.
For production, the article highlights companies that are leveraging innovative methods to 'sell vaccines in the US that take just weeks to produce'. These involve processes that differ from the traditional method of growing the virus by getting it to replicate in chicken eggs, which can take months, and allows the flu virus time to mutate, limiting the effectiveness of the vaccine.
The article also discusses accelerated delivery mechanisms that 'would eliminate the hassle of handling a liquid vaccine that needs to be refrigerated', as well as methods to combat the virus 'by altering the behaviour of immune cells, which respond to the proteins on the surface of a pathogen such as the flu virus'.
In our work with BARDA (Biomedical Advanced Research and Development Authority) related to rapid pandemic response, we focused on microbial quality control (QC) testing in manufacturing and its contribution to the production process for vaccines.
Throughout the manufacturing process for vaccines an assortment of microbial QC assays must be performed to confirm that microbial contaminants are maintained within appropriate limits (e.g. purification steps), or have been completely removed (e.g. final fill). Additionally, environmental monitoring (EM) consisting of air, surface and personnel testing is carried out throughout production to confirm that the manufacturing process is performed under controlled conditions.
Microbial QC testing requires from three to 14 days to complete, is performed at multiple production steps, and progression to each subsequent step may be contingent upon passing these lengthy tests (e.g. 14 days for sterility). Consequently such testing can have significant additive impacts on the production cycle. These procedures also require substantial resources (i.e. labour and materials) to perform.
Using automated, non-destructive, rapid micro methods such as the Growth Direct System in the QC lab can reduce the turn-around times for test results. This could have a significant impact on influenza vaccine production cycle time, costs, and the timing of product distribution to the market.
To learn more about the application of automated, rapid detection and enumeration to vaccines, read the application note 'Rapid Enumeration of Bioburden in a Model Sample Matrix for Influenza Vaccine using the Growth Direct System' located in our Resource Library.