Feasibility Study – Development of a GMP Compliant Suite in an Existing Research Laboratory Complex

As part of the development of its pharmaceutical pipeline, our client needed a feasibility study for the conversion of a laboratory area into a manufacturing and filling suite for products intended for clinical trials.

Genipro was mandated to carry out the feasibility study which had to cover various aspects, especially the architecture, utility systems, manufacturing process support and filling, to evaluate the feasibility, cost and schedule while minimizing the impact on the occupants and activities in the existing building. The study also had to determine the prerequisites for the suite to be reconverted into a level 2 bio-containment laboratory at a later date.

We started the mandate with the writing of a technical specifications document which determined the desired outcome. We then analyzed the capacity and constraints of the existing premises in order to identify the gaps between present and future installations. Because of the location of the new suite, the integration of a new ventilation system was challenging and required the collaboration of several disciplines to determine the best technical approach to achieve this. We were able to determine the work to be carried out, define the sequence and method of carrying out the work to minimize the impact on the building's occupants and then develop a schedule and cost estimate. The client appreciated the quality of the study and Genipro's approach because we carry out each project as if we were in the client's shoes.