Manufacturing vaccines is a complicated business. Not just because the production process isn't simple, but also because it involves people's health. The development of vaccines requires specific controls that will determine the quality of the final patent.
First there is the selection of small amounts of virus that will be kept under "ideal" conditions, preventing the virus from becoming either stronger or weaker.
Then there is the growing virus phase, in which the virus is placed in a "cell factory" allowing the virus cells to multiply.
During the separation phase, the virus will be separated from microscopic particles to which the viruses can attach themselves.
Sanofi goes with Intercim
The understanding of such manufacturing process is one of the key elements to master products quality and production units performances. Since 2003, Sanofi Pasteur (a division of Sanofi-aventis group) uses the Pertinence Suite solution to better understand, improve reliability and optimize industrial processes. The software solution will be used within the European and North American sites.
"Manufacture and guarantee the highest level of quality and safety for the patient and the optimum performances for the company are key objectives of process understanding. [...] The use of Pertinence Suite for understanding mechanisms which drive our complex processes is an asset to answer to this double requirement in an efficient manner."
René Labatut, VP Manufacturing of Sanofi Pasteur
With Intercim's solutions, Sanofi Pasteur can identify and set up in real-time parameters influencing the product quality and, moving forward, better control process variability. This is a recurrent challenge for the pharmaceutical industry which needs to consistently deliver vaccines on time, with a perfect traceability.
This deployment demonstrates the willingness to implement in a very operational manner the approach promoted by the regulatory bodies through the ICH Quality by Design (QbD). This approach aims at mastering manufactruring processes and efficiently sharing with the authorities the understanding of the mechanisms which drive products critical quality attributes.
See also what Dassault Systèmes solutions can offer the life sciences industry