Global facility engineering company M+W Group and GE Healthcare announced last month a partnership to bring biopharma manufacturing capability to developing countries. The idea is to join M+W's bio-engineering and construction expertise with GE's knowledge of biopharma production equipment to lessen emerging-country dependence on imported vaccines, insulin and biosimilars.
We spoke with Tobias Luecke, managing director at life science subsidiary M+W Process Industries, about pharma plant design trends and the GE collaboration. Here's the edited summary.
What's top of mind among your clients in biopharma facility design and construction?
Luecke: Lean manufacturing--it's a common request. Clients are under enormous cost pressures and have mandates to reduce capex spending.
Lean is about the avoidance of unnecessary handling, unnecessary steps, which the automobile industry has become very good at. We want short distances, little motion. Lean also is about avoidance of "waste"--energy, materials movement, people movement.
This is where we can learn from the automobile industry. We have some experts from car manufacturing on our lean design teams. Car manufacturers have to be able to adapt facilities for quick product changes. That's what pharma needs, especially in secondary manufacturing [packaging]. That's where you have to move a lot of material with high flexibility, which requires lean techniques.
How do you implement lean processes in building design?
Luecke: We start by analyzing material flow and then attempt to minimize it. The same for flow on small-scale events, like the handling of substances. We look at ergonomics to help make each worker very efficient.
You have to be well organized, especially with single-use technology, which requires manual intervention.
Will single-use technology be part of your initiative with GE Healthcare?
Luecke: Yes. Disposable technology is a key development over the last decade. We're pretty comfortable with it.
The primary target of our alliance with GE Healthcare is developing countries. We want to be a one-stop shop to governments and pharma companies. Together, we'll support organizations in scale-up, training, product registration, and commissioning.
What else are your clients looking for in facility design?
Luecke: Environmental sustainability is becoming more important, especially in America. Many ask for LEED certification at the platinum or gold level [LEED is the U.S. Green Building Council's Leadership in Energy and Environmental Design program]. Some want platinum, but it can be too expensive. So that client may make compromises and achieve the gold level instead.
How have facility requirements changed over the last few years?
Luecke: The days of central manufacturing facilities are over! Facility design is now driven by the market to be served. Facilities themselves are closer to the markets.
How do you resolve the issue of build new versus expand or renovate an existing facility?
Luecke: This is the primary facilities question.
I see some tendencies. In Western Europe and America, where there are sufficient facilities and capacity, we talk more about renovation. The facilities are already in compliance. Remodeling on a limited scale reduces regulatory involvement.
In Eastern Europe, a lot of facilities are not in compliance. So there we are likely to build new plants.
Asia is a combination of new construction and remodeling. In some countries, there is great effort on GMP compliance to meet the standards of the countries to which they want to export. - George Miller