At the heart of the Laboratory of the Future facility a unique initiative is set to pave the way for the development of new cell and gene therapies. A so-called pre-GMP lab has been established as an entirely separate lab within a lab. The new facility is available to business and academia.
Vecura, part of Karolinska University Hospital, is located at the centre of Campus Flemingsberg, and is one of Sweden’s largest facilities for the development of Advanced Therapy Medicinal Products (ATMP)*. A place where researchers and businesses in the field can come to produce materials.
However, the environment at Vecura requires projects to be at an advanced stage of development. Approaches and routines at Vecura differ in many ways from ordinary laboratories, something that can mean that some projects are temporarily delayed.
“Projects risk taking unnecessarily long periods if they are forced to conduct tests and optimisations once they have come to Vecura. This can be both costly and time-consuming for their development,” says Lars Frelin, associate professor and co-ordinator for Laboratory of the Future ANA8, Karolinska Institutet.
It is for these reasons that a preliminary step to Vecura is to be established at the end of the year: a so-called pre-GMP lab.
“The step from research lab to GMP production is significant and demands careful preparation of processes. We’ll benefit considerably from having process development in projects in place before they come to Vecura,” says Pontus Blomberg, operations manager at Karolinska Centre for Cell Therapy, Karolinska University Hospital.
The pre-GMP lab comprises five separate laboratories, largely structured as a real GMP lab with similar equipment and standards. Through the Laboratory of the Future, users of the pre-GMP lab also have access to advanced equipment in, for example, flow cytometry, confocal microscopy and mass spectrometry.
“We’re doing this to ensure flexibility, and to offer the right conditions for as many projects as possible. The overarching aim is to promote the development of new cell and gene therapies,” says Anna Pasetto, operations director at the pre-GMP lab.
Adjacent to the labs, there is also office space available for projects that need to work on-site for longer periods, and a dedicated cool room.
Access to KI’s core-facilities
Under the auspices of ANA8, there is also access to several of Karolinska Institutet’s core-facilities that offer world-class research platforms and equipment.
“This will be the ideal place to test your project, with the possibility to put things on hold and address potential mistakes and flaws that you may come up against. You can also optimise your methods so that subsequent production times are as efficient as possible. This will be an environment where you can optimise your projects to ensure you have the best possible potential to continue the development of advanced therapeutic drugs and cells for transplantation at Vecura,” says Pasetto.
The lab environment will also be used for teaching, with some lab walls made of glass to more easily show methods and procedures to people outside the lab, for example students and visiting researchers.
“Staff at the pre-GMP lab can also contribute with relevant knowledge in terms of documentation related to projects. When you work with something that from then on can be used clinically, there are stricter rules in terms of reporting and documentation than is otherwise the case,” says Pasetto.
“We’re here to make the step to production at Vecura as simple and as smooth as possible.”
* ATMP is based on cells, tissues or genes. Read more here.