This project aims to increase the production efficiency of a toxin intended for vaccine production, while optimizing chromatography for purification. Through comprehensive process reengineering and improved validation of cleaning recipes, it reinforces the reliability of operations.
2024 - 15 months
France
Health and life science
In a pharmaceutical sector subject to ever more stringent quality and effectiveness requirements, this project meets the need to optimize the production chain for active vaccine substances. The approach is based on increasing the production efficiency of a specific toxin and on optimizing the chromatography used for purification. The teams work on several aspects: the reengineering of processes including the functional analysis of skids and chromatography columns, as well as the reduction of scale and the troubleshooting of installations.
In addition, the optimization of operations is supported by the validation of cleaning recipes as part of the CIP and the destocking of columns. To ensure a gradual transition to industrial mode, continuously chromatography preparation, column conditioning and resin distribution are carried out, followed by classroom tests, scale-up and finally commissioning with qualification (IQ-OQ tests). This integrated approach guarantees improved performance while complying with regulatory constraints.
The customer is looking for advanced expertise capable of significantly increasing manufacturing efficiency while guaranteeing high quality purification. He involves a reengineering of processes involving a thorough analysis of chromatography equipment and the optimization of operations. The establishment of a destocking and CIP procedure, as well as a controlled transition from the scale of tests to industry, are essential to secure and make the entire vaccine production process reliable.
Increase production efficiency through precise reengineering.
Optimize the chromatography process and purification.
Implement a validated CIP and destocking protocol.
The mission is based on a comprehensive technical approach designed to improve purification performance and vaccine production. It includes the reengineering of processes in order to optimize the functional analysis of equipment — especially skids and chromatography columns — and to reduce the scale while troubleshooting anomalies. Optimizing operations involves the validation of cleaning recipes via CIP, as well as the conditioning and preparation of columns, thus ensuring a smooth transition from room testing to industrial commissioning.
Optimize the functional analysis of installations and the reduction of scale.
Validate cleaning recipes using using using CIP protocols.
Ensure the optimal conditioning and preparation of the columns.
In addition to cookies that are strictly necessary for the operation of this website, Vulcain Engineering Group uses cookies and other tracking tools to remember your preferences and offer you additional services, to measure the performance of our website.
You can click on “Accept all cookies” to consent to the uses mentioned above, click on “Cookie Settings” to configure your choices, or click on “Reject all” to refuse all optional cookies.
