Irish pharmaceutical plant design specialist PM Group has developed a new system of standardised disposable components which has the potential to dramatically reduce costs, improve efficiency and enhance the sustainability of the latest generation of biopharmaceutical plants.
The global pharmaceutical industry has undergone profound changes over the past two decades with products and the manufacturing process to produce them fundamentally altered as a result. The advent of large molecule biopharmaceuticals has led to the development of a very different type of pharmaceutical facility, one that is more akin to a modern brewery to a traditional synthetic pharmaceutical plant.
But these plants are changing and creating new demands. "A traditional biopharmaceutical plant such as the Pfizer facility in Grangecastle in Dublin costs around €700 million to build," says PM Group biotechnology consultant Dave Wolton. "But there is a new type of plant, the factory of the future, which is much smaller in scale and costs just €150 million to build."
This smaller scale is achieved through the concentration of the end product and it facilitates significant design changes. Massive stainless steel vessels that require intensive cleaning processes on a continuous basis are required for traditional plants. But the smaller scale processes in the new plants can be carried out in 3,000 litre disposable plastic bags.
These new plants are far more energy efficient and environmentally sustainable than their forerunners. For example, water consumption is reduced by 80 per cent.
Wolton compares this evolution to the move from glass to plastic for intravenous drips. “Until the Vietnam War, glass bottles were used for drips and then they switched to plastic bags and these proved much more efficient and greatly reduced the potential for cross-contamination and so on.”
The problem is that the bags and other ancillary disposable parts are non-standard. Each plant requires bags specifically designed and manufactured for it. This naturally leads to higher costs – up to €2,000 per bag, and long delivery times for new supplies, sometimes several months.
The answer to the problem is to standardise the bags – not so much to make every plant use the same bags but to use standard specifications for the bags they use. “The closest analogy is car tyres,” Wolton says. “Years ago if you had a Mercedes and needed to change the tyres you had to get tyres made and supplied by Mercedes. Then someone came up with a system of tyre codes which allowed motorists buy tyres from any vendor.”
Each tyre type was given a unique code and buyers could be confident that tyres with a particular code, regardless of manufacturer, would fit their car. The result was increased competition and quite dramatic price drops. The same results will apply to the biotechnology sector, according to Wolton.
“At the moment, all the bags are made to order. Once you move to mass manufacture the price will drop. Already we have seen a fall to €600 for certain bags. That is still quite a lot but we expect it to drop even further – perhaps to €300.”
These cost benefits have wider societal implications. “These plants are making the most expensive injectable drugs on the market today,” Wolton says. “By reducing the construction cost of the plant and its running costs not only is it becoming greener and more efficient but there will also be the impact of reducing the price of the drugs manufactured. This will enable more people to benefit from these expensive drugs.”
The standardisation extends beyond the bags to the filters and the manifold arrangements required to connect them into the other elements of the manufacturing process. PM Group has come up with standardised designs for them all – each with its own part number. This is known as the Standardised Disposables Design (SDD). Manufacturers pay PM a small fee each time an item is manufactured with one of the part numbers. “We already have two of the main manufacturers signed up and we are talking to five others at present,” he says.
The potential benefits of the invention are enormous. “Delivery times for disposable parts are anywhere between eight weeks and three months at the moment but we are now moving towards off-the-shelf purchasing. This will happen because you will have six or eight major pharmaceutical companies all buying the same things.”
This will also have an impact on the design of the plants. “At present, all of the major plants have to have at least six months’ stock of disposables in a warehouse. They can’t afford to run out of them. With standardised parts they will be able to order in replacement stocks within a week, regardless of where they are located. This means they won’t have to carry the cost of that inventory and won’t need to have huge warehouses attached to the plant.”
Looking to the future, Wolton says the invention will become the standard for the industry. “When I started working on this three years ago I couldn’t believe it when I found that no one else was doing it. No one had spotted this gap in the market. The likelihood of anyone else trying to replicate what we are doing is very small – the last thing anyone wants now is competing standards.”
BARRY McCALL
