Bringing a product to market as quickly as possible in the most cost-effective way is a growing concern for pharmaceutical manufacturers. Modular project delivery allows more control of the delivery, resulting in significant time and cost efficiencies.

The pharmaceutical industry is coming under increasing pressure to supply highquality products at lower cost to the market. Whether a pharmaceutical company, contract manufacturer or producer of generic drugs, the need to be cost efficient and risk conscientious increases every day. It is all about proving the business case for the product and bringing it to market as fast as possible, with the lowest financial risk.

A vital part of the product’s journey to market is the construction and delivery of the facility in which the product will be manufactured. Delays, cost overruns and inferior quality can be devastating for the business case.

Modular fabrication

Swedish company Pharmadule has developed a delivery process for new facilities and expansions to address these concerns. Its concept, which was developed in the mid- 1980s, encompasses off-site fabrication of the facility in an industrial environment.

The pharmaceutical manufacturing building is made up of large modules, which are fabricated in the workshop, and all facility installations and services, such as heat ventilation and air conditioning and piping, are installed and architectural finishes completed in the workshop.

Even the process equipment for manufacturing the product are installed and pre-tested in the workshop. The modules are then transported to the final site and assembled together to form the final completed facility. The facility and the process equipment are qualified IQ/OQ.

‘This method allows us to complete as much as 85% of a new pharmaceutical plant in the workshop, leaving only 15% of the work for the final site,’ explains Ulf Danielsson, VP sales and marketing at Pharmadule. ‘The fact that we perform so much of our work off site gives us the ability to better control the process and outcome. Our attributes are fast delivery, high predictability and the right quality. A faster delivery means that you can launch your product on to the market much earlier. It also opens up the possibility for you to defer the decision of spending major capital money until you have a better defined product or process, and enables you to still meet the same launch date as you would have if you had implemented the project in the traditional way.’

Exceptional track record

Since its inception in 1986, Pharmadule has delivered more than 60 projects all over the world to both large and small pharmaceutical and biopharmaceutical companies. Among its customers are companies such as Eli Lilly, Merck & Co Inc, GSK Biologicals, Baxter and Genentech.

The deliveries show an exceptional track record in terms of predictability. More than 70% of the projects have come in at 3% or less of the initially estimated project cost and none has come in over 10%. Over 50% of the projects have come in on the estimated delivery time and another 30% with less than two months’ delay.

‘Our concept is very much about controlling the entire project delivery chain, from the early design phases to fabrication, installation and IQ/OQ qualification,’ says Danielsson. ‘We integrate the design and qualification work with the fabrication. With this method and the off-site fabrication, we can monitor and control the delivery process, thus avoiding delays and cost overruns. In this way, we provide certainty to our clients and minimise the owner’s risks.’

Method of the future

Modular approaches and off-site construction are gaining more interest in the industry. The ability to better control the delivery process and bring value to the business case is very appealing.

‘As a pioneer of modular fabrication in our industry, we see a rapidly increasing interest in our concept,’ adds Danielsson. ‘The modular approach is certainly the approach for the future.’