Sön 14 jul / År 42 / Nr 3 2024

Medicon Village joins forces with Region Skåne and Lund University to plan an ATMP centre

Region Skåne, Lund University and Medicon Village plan to create opportunities for advanced cell and gene therapies at the frontiers of the field. The three partners will tie existing infrastructure to cutting edge academic and industrial competence. The aim is to establish an Advanced Therapy Medicinal Product (ATMP) Centre at Medicon Village Science Park – to drive the transition from bench to clinic faster.

Cell and gene therapies are Advanced Therapy Medicinal Products (ATMPs) and have the promise to deliver cure to terminal and disabling diseases, such as Parkinson’s, cancer, Alzheimer’s and muscular dystrophy. These novel drugs have the potential to halt or even reverse symptoms of diseases that have previously been untreatable. ATMPs are one of today’s hottest medical research fields, although most of the products are still in an early phase of development. In an effort to speed up the R&D process from bench to bedside, Region Skåne, Lund University and Medicon Village have jointly announced that they plan an ATMP Centre that will gather all necessary facilities, equipment and competences needed to develop, manufacture and store ATMPs in one place.

Challenging Paradigm Shift
The paradigm shift to ATMPs creates challenges in terms of how to make these therapies commercially available. Independently of the type of product or indication, the production of regenerative medicines is highly complex and there is therefore a need for an ATMP centre.
There are many issues that must be addressed. For instance, manufacturing capacity and costs, including flexibility and scalability. Other issues concern regulatory and quality programmes. In addition, all work has to be performed in laboratories and cleanrooms with special classifications. Finally, there are important ethical questions to be considered.
Much of the development is carried out by academic scientists and clinicians affiliated with university hospitals or small to medium size enterprises. Many of these however lack the regulatory expertise, experience and resources to establish and operate Good Manufacturing Practice (GMP) compliant manufacturing processes.

Access to Cleanrooms and Competence
The ATMP centre will be located at Medicon Village Science Park comprising of a number of cleanrooms with different classifications and necessary supporting infrastructure.

Medicon Village Science Park is a thriving life science community that has the potential to emerge to the forefront in the field of advanced therapies, both within academia and in companies, such as Idogen and Xintela. The close proximity between such companies and Skåne University Hospital, as well as cleanrooms, advanced equipment and regulatory expertise benefit all parties.
Through collaboration with clinicians, academic scientists and CROs, ATMP-developing companies will have access to the necessary knowledge and expertise in order to manufacture these advanced therapies in line with European GMP and other stringent national and European regulations.
”The conditions to succeed with the establishment of the ATMP centre are very good in Skåne and, additionally, include big opportunities to develop life science in Skåne and all of Sweden. Region Skåne is a co-financer and fully supports the venture,” says Hannie Lundgren, Research Director at Region Skåne.
Navigating the R&D process from lab bench to patient bedside requires both skills and creativity, but also collaboration with partners and CRO-companies with the right knowledge and technologies. Collaboration is the cornerstone when developing novel therapies and diagnostics. In most cases, involving the right expert at the right time will save both time and money.
“One of the centre’s goals is to offer competence in how to bring these products from lab to market by promoting interaction and collaboration between academic research groups, clinicians, biotech companies and service providers,” explains Kerstin Jakobsson, Vice President of Medicon Village.

A Thriving Life Science Community
At Medicon Village Science Park there are more than 70 experienced service providers and CRO companies. The science park provides access to state-of-the art lab services and equipment. In addition, there are many internationally competitive preclinical and clinical research programmes in hematology, diabetes, neuroscience and cancer at Lund University and Skåne University Hospital.
“By bringing together scientists from Lund University with clinicians from the University Hospital and companies in the field of advanced therapies, we create a strong life science community at Medicon Village,” adds Kerstin Jakobsson.
There are also many researchers here working in other life science areas, as well companies within biotech, pharma, medical devices etc. Today more than 1,600 people from research, innovation and commercialisation work in more than 120 different organisations at Medicon Village Science Park.
It’s close to Lund University, the University’s BioMedical Centre (BMC) and the University Hospital (SUS), as well as the European Spallation Source (ESS) and the MAX IV Laboratory. Furthermore, Copenhagen Airport is reached in about 60 minutes by train and Copenhagen is just across ’The Bridge’. In other words, Medicon Village Science Park is an excellent place to be when it comes to R&D and commercial use of products and services for people’s health and wellbeing.

Fact box:
Medicon Village Science Park
Number of member organisations: more than 120
Member employees: more than 1,600
Space: 80,000 m2
Laboratories: 40,000 m2
Owner: Mats Paulsson’s Foundation for Research, Innovation and Social Benefits. The terms of the foundation stipulate that all profits must be re-invested in research and innovation.