And with that, she disappears into the facility’s labyrinth of labs with the next group of interested visitors: researchers, companies, doctoral students, and curious onlookers. Today, the pre-GMP facility, located behind locked doors in sterile rooms at the Faculty of Medicine, is holding an Open House, and the line for the lab tour winds through the hallway.
But first, the slightly complicated names explained. Cell and gene therapies, also known as ATMPs, or Advanced Therapy Medicinal Products, are advanced therapies based on genes and living cells. These are particularly complex and expensive to test and manufacture before they can be administered to patients. GMP stands for Good Manufacturing Practice, a quality assurance system for the manufacture of pharmaceuticals.
In a pre-GMP facility (pre, as in prior to), such as the one headed by Sara Nolbrant, researchers can pre-test and develop techniques and processes on a small scale, hit snags, refine, calibrate, find the right contacts, and scale up. Only then are the tested protocols transferred to a GMP facility, while the price tag, of course, rises significantly. If mistakes are made on a large scale, it can cost the researcher or the company dearly. So it’s better to make the mistakes on a small scale first, here at the pre-GMP facility.
“We are, in other words, a support function, a training ground, for researchers who want to translate their research and innovations into clinical treatments more quickly. It’s about making protocols more industry-ready, clear, documentable, and scalable. From ‘it works in a bottle’ to ‘it works as a process. The facility does not replace GMP production, but it can make the transition less uncertain by allowing methodologies and workflows to settle in well in advance", says Sara Nolbrant, leading us into the next, even more sterile room.
A winding path
Because it’s rarely just an extra check that’s missing, but an entire way of working, for the innovation process to reach its goal. And this is where the pre-GMP facility comes in: not as a shortcut promising miracles, but as a practical environment to make research results more robust, reproducible, and ready for the next level of requirements.
"The path from the lab bench to the hospital bed for new therapies is long and winding. Our task is to serve as the bridge between the research community and the hospital."
Pre-GMP in Lund works closely with the local so-called ATMP ecosystem. This encompasses the stages from idea to clinic: Region Skåne’s ATMP Center at Skåne University Hospital, LU Innovation, and Life Science companies.
Lower cost
Director Sara Nolbrant has long been fascinated by the potential of stem cells to cure previously incurable diseases.
"During the ten years I’ve worked in this field, enormous progress has been made. The question has shifted from “Can it be done?” to “How should it be done, and how can we reach patients?” Here, I believe that pre-GMP and the work we are undertaking are part of the answer."
In the tour line, the atmosphere is friendly; coffee and snacks have been set out, along with quizzes and chit-chat among like-minded people, while the pre-GMP team answers questions and works through the line in small groups, which are led into the white labs via several airlocks.
Pre-GMP can thus be likened to a training and testing environment for future GMP manufacturing. Here, researchers can test, adjust, and refine processes that will later need to function in a strictly regulated pharmaceutical environment, but without having to immediately bear the full cost and burden associated with full GMP compliance. At the facility, researchers and development teams can receive support with process development for advanced therapy medicinal products (ATMPs), upscaling in bioreactors, and the development of analytical methods for quality testing.
The goal is for researchers to be able to answer the questions that inevitably arise sooner or later: How do we know it turned out right? How stable is it? Can it be replicated?
"A common misconception about our work is that our requirements are roughly as high as those in a GMP facility. But in pre-GMP, the requirements are lower, which means costs can be kept significantly lower," explains Sara Nolbrant.
Finding the right infrastructure
Small choices made early on—materials, workflow, analysis strategy, documentation—can later determine whether a project moves forward or gets stuck when traceability and quality requirements are tightened.
"We’d love to help ensure things are as right as possible right from the start. And the threshold should be low: we’re very open to no-strings-attached meetings and conversations", says Sara Nolbrant.
The facility was launched in Lund specifically because Lund has a strong tradition in stem cell research and regenerative medicine. A 2024 survey identified 27 ATMP products under development at the Faculty of Medicine, many at an early stage where the right infrastructure makes a crucial difference. At the same time, there is a clear ambition to link the Faculty of Medicine and LTH even more closely, where much of the enabling technology is being developed.
Exciting times for the field
Both internal and external users are welcome at the facility, from research groups to startups and larger companies.
"Sometimes collaboration involves hands-on work together in the lab environment. Sometimes it’s about finding the right path forward and connecting the researcher or company with the right player in the ecosystem. In some cases, this means direct support from us; in others, it means facilitating contact,” says Sara Nolbrant, continuing:
“It’s an exciting time for the field. I’m really looking forward to seeing where we stand in another ten years.”
