In recent years we have seen a switch from traditional bio-pharma manufacturing toward a novel approach using Isolation Technology (IT) as both a means and method for the delivery of sterile and non-sterile drugs. We have observed this across both large and small pharmaceuticals and in certain science and technology universities campuses across the US.

Have you heard these statements in our industry? “Give me an isolator and I can run cGMP products in a parking lot.”

Or this? “Facility is secondary — cover up my process train with a tent — that is all I need to run this bio-pharma product.”

And most recently, due to an unprecedented increase in construction cost: “The building cost came in too high. We cannot afford the building but we need the process. Can we get one without the building?”

All of the statements above, and others like them, are primarily made by process engineering and/or project engineering groups; whether they are realistic or impossible requests at the moment, they create frustration in facility engineering groups that, traditionally, tend to see everything in terms of fixed assets such as “buildings and equipment.”

Tradition has its role, and we learn from past experiences; however, progress cannot be stopped and one needs to constantly apply timeless concepts in the context of new technologies, current needs, and new cultures emerging around us. For example, concepts such as “functionally driven design” or “building is disappearing” that allow the intended function/process inside to take top priority are not new. They are well over 100 years old and we now see these concepts making their way into bio-pharma engineering as well.

Figure 1 shows a high-tech lab setting under a temporary inflated roof. It could even be set on a parking lot. Some utopian ideas can indeed become reality. This lab symbolizes the notion of “temporary operation” or “reduced time to market” or “trial production” or “emergency setting” — all are good answers to the realities in today’s life.

All of the facilities mentioned above use a particular type of IT for their clean and/or hazardous processes. Facilities using IT as their primary means of running cGMP batches remind us of the “ballroom” concept already well established among research labs — they allow researchers (bio-pharma operators in this case) to design and use their own workplace creatively — yet they meet all the stringent requirements and procedures of a cGMP facility.

The essence of the ballroom (multi-purpose room) concept is flexibility and creativity in operation and its ability to adapt to changes overtime. A secondary benefit is that the ballroom by design becomes a more agreeable and friendlier place to work, showcasing the technology and methodology in order to recruit/retain science talent for both business growth and client development.