Basic, Detailed Design & Execution Follow-Up for a new bio-production plant

Challenge

An American pharmaceutical company has recently decided to set up a new disruptive and flexible scalable bio-production plant in Europe in order to meet the needs for therapeutic antibodies. A french campus site has been chosen.
This new plant is the second facility of its kind after the one in the United States, and the first one on European ground and will employ J.POD® technology to deliver much-needed clinical and commercial manufacturing capacity for biologics.
Project consists in the construction of an industrial building, with a floor area of over 15,000 m², including production and quality control activities as well as a development laboratory.
Process equipment will be installed in modular prefabricated clean rooms and will be placed inside a ballroom which will be manufactured on site.
The new plant will meet FDA and GMP requirements for process, clean rooms and Clean Utilities.

Mission

ILS team supports Ingerop in the follow-up and review of General Contractor in charge of GMP-related activities such as process equipment, clean utilities, HVAC, clean rooms and BMS. ILS also supports client team when needed for the procurement of process equipment.
ILS team and its GMP expert is also the main contact for all regulatory topics.