Largest Single-use Based mAb Facility in the World
Challenge from the Client
Our CMO client was looking to do something radically different by creating a multi-product, multi-scale mAb facility that could flex the upstream capacity of their facility by 2000L intervals and generate 40,000 liters of production bioreactor capacity using single use bioreactors.
Our Approach & Solution
As a first in class facility, IPS had to think outside the box and develop an cFDA, USFDA and EU compliant facility that could eloquently deliver 40,000L of bioreactor capacity and incorporate all related office and lab capabilities in one facility. Working with the geometry of the existing campus, IPS process architects and process designers created a plan that would allow both upstreams to "cross-over" and use either downstream to allow efficient use of the plant capacity based on campaign timing.
The 38,000 square meter plant achieved it's nameplate and became a model for future plants that the customer went on to utilize IPS to design in other parts of Asia and Europe. The 2x10x2kL facility serves as one of the largest single use CMO production facilities in the world.