Securing strict GMP demands in fast delivery of oral solid dosage launch plant

As Novo Nordisk makes headway in the field of oral solid dosage with its highly anticipated diabetes treatment product, the company is using its location in Måløv, Denmark for a full-sized, generic and standalone launch facility. The company turned to NNE to assist in fast-track execution and GMP compliance for this strategically important project.

After encouraging results from phase II clinical trials, Novo Nordisk was not slow to initiate the establishment of a launch plant for the product to get it to the market fast. Since oral solid dosage (OSD) production is uncharted territory for Novo Nordisk, the company turned to NNE for our experience in OSD facility engineering. Besides, NNE was already handling the execution of the clinical phase III facility for the product – located across the street from the new launch plant.

Balancing fast-track delivery and flexible design

Time was a major success criteria in this project. The project team thus kept a strict focus on optimising processes to cut time and finish as fast as possible. “We have more or less designed and built at the same time”, says NNE Project Manager, Bo Lambertsen, and continues, “we shorted the detailed design phase significantly, getting tenders out very quickly so they could start construction. “For example, the concrete elements for the building were already ordered during the conceptual design. This was a long-lead item with 12-16 months delivery time, so it was crucial to get that order out in time.”

“We shorted the detailed design phase significantly, getting tenders out very quickly so they could start construction."

Bo Lambertsen, Project Manager, NNE

This approach, however, meant that NNE had to lock the scope for all parts of the building using concrete elements: facades, internal elements, etc. To get around this challenge – and allow for some flexibility – we did column beam systems and then used brick walls inside to have soft spots for easier access for docking. This was necessary to get the building put up as fast as possible.

To avoid losing construction time to bad weather, the largest tent in Denmark was installed over the site, weighing in at 260 tons of steel and 116,640 m³.  

Managing various partners and disciplines

Novo Nordisk also requested engineering support from Rambøll for executing the raw building and all non-GMP deliveries to take advantage of a strong cooperation between the two engineering companies. In essence, NNE is responsible for all of the GMP-relevant packages such as HVAC, cleanrooms, clean utilities and building management systems, whereas Rambøll has the non-GMP packages such as structure, black utilities, plumbing, and non-critical elements. Furthermore, NNE commissions all work to ensure a high quality standard of all non-GMP packages, as they supply to the GMP-related packages. 

“This was quite a complex project in terms of the scope divisions between Rambøll, NNE and our own people, but also thanks to NNE’s cross-disciplinary coordination skills, we were able to maintain a successful collaboration and meet the fast-track deadline”.

Lars Eriksen, Project Director, Novo Nordisk

A strong collaboration between Novo Nordisk and both engineering vendors were key to success. Project Director at Novo Nordisk, Lars Eriksen, elaborates:

“This was quite a complex project in terms of the scope divisions between Rambøll, NNE and our own people, but also thanks to NNE’s cross-disciplinary coordination skills, we were able to maintain a successful collaboration and meet the fast-track deadline”.

Incorporating a second project into the same timeline

Not only is the NNE team focused on coordination, but also on agile reactions to inevitable sudden changes in the world of pharma. When Novo Nordisk needed a quality control laboratory, the NNE team added engineers and fluidly merged them on-site to handle the new need without compromising on the existing project.

Despite the challenge of integrating a laboratory into a facility which is already in the design phase, the team finished the basic design approximately at the same time that it finished the main basic design. We were thus able to continue the detailed design as one project instead of having two projects running simultaneously.

The NNE team completed its main deliveries at the end of 2017, and is currently supporting Novo Nordisk in the final operational and performance qualification activities.

 

 

Fact box

Customer

Novo Nordisk

Country

Denmark

Project duration

2015 – 2018

Size

9,700 m2 (3.5 levels)

Total investment cost

DKK ~1 billion

Services provided

Conceptual design, basic design, detailed design, procurement, construction support, installation, commissioning and qualification