Niels Guldager

Global Technology Partner - Biotech and API

"As cell and gene therapies progress through clinical to market supply, we will see a new range of facilities where supply chain, logistics, segregation and automation will be crucial factors in releasing the potential of personalised medicine."

Niels Guldager is an expert within bioprocess and technology and heads NNE's biopharmaceuticals design group.

Niels focus is on process and technology in front-end project activities. He has a strong ability to capture customer strategy and requirements and transform these inputs into a well-defined process and facility design scope.

Niels Guldager is currently engaged in single-use technology community work for the industry organisations PDA and ISPE. He is also a member of PDA’s task force for Gene and Cell Based Therapies and holds the Certified Pharmaceutical Industry Professional™ certification from ISPE.

Niels Guldager holds a Master’s degree in Chemical Engineering from the Technical University of Denmark. He started his career at Novo Nordisk as a production engineer, responsible for upstream production of recombinant human insulin. In this role, he also facilitated production of clinical batches and manufacturing technology transfer for next generation products. Later, Niels moved on to downstream manufacturing.

The future will present unforeseen productivity/cost relationships by introducing true continuous biotech processing

Niels Guldager

What's your view on the industry?

"Biotech manufacturing will branch out to cover a much more diverse field than the traditional fed-batch and step-by-step purification process that have paved the way for industry and therapeutic success. The future will present unforeseen productivity/cost relationships by introducing true continuous biotech processing. And as cell and gene therapies progress through clinical to market supply, we will see a new range of facilities where supply chain, logistics, segregation and automation will be crucial factors in releasing the potential of personalised medicine.”

Why work in this industry?

"NNE plays an important role in making diabetes therapies available to the world. I have been fortunate enough to be able to contribute to this effort over the years and I have always been excited to see the potential of really efficient large scale biotech manufacturing. But the world is a big place – there is still a lot of ground to cover when it comes to biotech therapies for all, so the challenge is certainly there. The biotech industry has a pioneering and free-thinking mindset that makes this work extremely motivating, so I am sure that we will get there in the future too."

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Expert in:

  • Biopharmaceuticals
  • Industrial biotech
  • Facility design
  • Monoclonal antibodies
  • Bioprocess design and optimisation
  • Feasibility and concept studies
  • Biotech bulk
  • Single-use technology
  • Logistics, layout and design

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