Transferring state-of-the-art device production across borders

A competitive cost level and the company’s overall internationalisation strategy of increasing presence in China were the motivational factors for Novo Nordisk’s decision to transfer the assembly and packaging of its drug delivery device, NovoPen®4, from Denmark to China. NNE provided support throughout the transfer project.

25 years ago, Danish pharmaceutical company Novo Nordisk, revolutionised diabetes care with the launch of the first insulin pen – a device that set new standards in convenient and precise delivery of insulin and eliminated the burdens and social inhibition that the use of vials and syringes implied for people with diabetes. The latest generation, NovoPen®4, administers insulin subcutaneously, that is under the skin, and is now the preferred method of delivery for 97 percent of people with diabetes.

The transfer project aimed to produce NovoPen®4 locally in China as of end 2008 - at a significantly reduced unit cost and to quadruple the production capacity by September 2010.

Installation without production shutdown

NNE supported Novo Nordisk throughout the project – from the basic design to performance qualification and handover of the new production equipment. One of the main challenges was to maintain a consistent supply of products and components during the transfer. This was solved by purchasing new equipment and installing it in China, while the existing manufacturing equipment was still in operation in Denmark. As soon as the first production line was up and running in China, the remaining production lines were shut down and transferred one by one.

To reduce the commissioning and qualification time, NNE applied a risk-based approach to ensure maximum focus on high-probability/high-impact risks. And to strengthen qualification efficiency between China and Denmark, an electronic test system, eTIMS, was introduced to handle all processes ranging from requirement specifications, test plans and test execution to approvals.

Prioritising people skills to optimise production

NNE trained Novo Nordisk staff at both sites in cGMP, eTIMS, Six Sigma and statistical process control tools as well as in how to set up qualification strategies. We also helped prepare requirement specifications, eTIMS test plans and FMEA (risk assessment by failure mode and effects analysis), and assisted in executing and reporting on commissioning and qualification activities.

The project was started up in January 2008 and was successfully completed in September 2010. A strong and fruitful cooperation between project members from both companies ensured that all success criteria were met.

Quick facts

Customer

Novo Nordisk (China) Pharmaceuticals Co. Ltd.

Country

China

Project duration

Jan. 2008 – Sep. 2010

Total investment cost

USD 12 million

Services provided

Process engineering, quality engineering, procurement and project management, training