Conversion of a BSL2 laboratory into a manufacturing suite for clinical biologic drug substances

Our client wanted to convert a level 2 biocontainment laboratory into an ISO8 class manufacturing facility for the production of biotechnological drug substances for clinical products.

Genipro was mandated to define the technical specifications and identify changes required to the premises, i.e. building, ventilation system and equipment, to meet regulatory requirements for the suite’s new intended use.

The main challenge was to find an adequate compromise between the constraints related to the existing facilities and systems, the regulatory elements required for the new intended use of the room and the client's schedule and budget.Thanks to our team of experts and our experience with similar facilities, we were able to identify low-cost and practical solutions while minimizing modifications, thus allowing us to meet the client's business objectives.