Henriette Schubert

Global Technology Partner - Facility design, laboratories

"With the challenges of autologous therapies, where there is no second chance to redo the batch, there is a focus on how to develop new GMP and biocontainment compliant process equipment, and on how to establish sustainable, cost efficient and compliant manufacturing capacity that meet market demands."

Henriette Schubert is an expert in architecture, biocontainment and GMP facility design. With an emphasis on GMP demands and interdisciplinary biocontainment engineering, Henriette's key focus is on consulting assignments that target the basis for decision and basis for design, front-end studies and facility design concepts.

Henriette Schubert qualified as an architect (Cand. Arch/Architect MAA) in 1992 from the Royal Danish Academy of Fine Arts in Copenhagen. She has worked with life science projects for most of her professional life and has acquired a profound knowledge and insight into interdisciplinary facility design for biocontainment and cGMP facilities. Today, Henriette also specialises in facilities for tailored therapies/personalised medicine, combining her laboratory operations experience with her insight into the synergies and conflicts between GMP and biocontainment.

Henriette Schubert has worked on pharma and biotech projects in Scandinavia, Europe, the USA, Russia, India and China. She has been a member of ABSA since 2007 and is also a member of the Nordic Biosafety Group, IVBWG (International Veterinary Work Group) and EBSA. Henriette is a regular speaker at conferences and symposiums.

The current expectations to the big breakthrough of tailored therapies is underlined by more than 10,000 ongoing FDA clinical trials.

Henriette Schubert

What's your view on the industry?

"Understandably, the primary focal points in the industry with regards to R&D visions are bringing products to market, plus study, development or research programmes. However, being in compliance with both GMP and biocontainment standards is a prerequisite for being in business. GMP traditionally gets a lot of focus, but biocontainment issues, protection of employees and safeguarding the surrounding environment needs equal attention.

The combination of GMP and containment compliance is a relevant challenge within the personalised medicine segment. The current expectations to the big breakthrough of tailored therapies is underlined by more than 10,000 ongoing FDA clinical trials. With the challenges of autologous therapies, where there is no second chance to redo the batch, there is a focus on how to develop new GMP and biocontainment compliant process equipment, and on how to establish sustainable, cost efficient and compliant manufacturing capacity that meet market demands. These challenges are unique and call for unique concepts and partnerships to enable the full potential of tailored therapies. This will set the scene in the years to come."

Why work in this industry?

"Working with GMP and biocontainment gives me a unique opportunity to contribute to projects where improving human and animal health is the main mission. It is a constant motivation that GMP and biocontainment facility design is a professional challenge that goes well with a holistic approach and a structured mindset, as well as the need to understand processes and work procedures."

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Expert in:

  • Biorisk assessments and project specific biocontainment typologies
  • User requirement specifications
  • Interdisciplinary biocontainment solutions
  • Facility design for facilities with biocontainment, GMO and GMP requirements
  • Translation of process into facility design
  • Facility design of bio manufacturing facilities, laboratories, small and large animal research facilities, cleanroom and vaccine facilities
  • Feasibility and concept studies
  • Logistics, layout and design

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