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Pre-GMP facility

Developing a Pre-GMP facility for vectors and genetically modified cells.

Lead: Karolinska Institutet – Matti Sällberg

Involved partners: Vecura, SLL, Cytiva AB, RISE

Publications

”Identification and Clinical Application of Immunological Receptors Targeting Mutated Antigens Expressed by Solid Tumors.” https://pubmed.ncbi.nlm.nih.gov/33007884/

”Chronic Viral Liver Diseases: Approaching the Liver Using T Cell Receptor-Mediated Gene Technologies.” https://pubmed.ncbi.nlm.nih.gov/32560123/

Project aims

The Pre-GMP facility was created within a Centre for Advanced Medical Products (CAMP) project to support researchers and biotech industries (e.g. academia, clinic and SMEs) to successfully overcome road blocks in the process of developing ATMPs.

The first aim of the project has been to build the facility according to the requirements necessary to meet the “clean room” criteria. This is particularly important because it ensures that we can work in the facility with conditions close to real GMP-classified environment.

The pre-GMP facility is mainly focused on projects involving the development of new gene delivery tools/vectors and genetic modification of cells. In the facility it will be possible to develop new products and protocols, test new devices for production, purification and analysis.

Examples of tasks and actions:

The first project in the facility will be to establish SOPs for the production of viral vectors suitable for transduction of cloned T cell receptors (TCRs) and chimeric antigen receptors (CARs) into T and NK cells (in collaboration with Evren Alici, KI). The pre-GMP facility will be immediately offered to CAMP partners for process and SOP development in this area. Several CAMP projects can easily be introduced to the facility. Currently production of new viral vectors and expansion and transfection protocols for T cells are anticipated to start within the facility.

Other projects that will soon start in the facility are:

  • Production of viral vectors (KI, Vecura and GE Healthcare)
  • Technologies and SOPs will be established for the most attractive viral vector systems, also including DNA and RNA. Suitable purification SOPs will be developed with evaluation of purification and chromatography systems. Analysis protocols will be set.
  • Establishing SOPs for transduction of cells (KI, Vecura, and GE Healthcare)
  • SOPs for transduction of T cells and NK cells with TCRs and CAR-T cells will be set. Analysis of transduction efficiency and reproducibility is set by flow cytometry.

Interview with Project Leader

Hi Matti Sällberg!

What is the need your project addresses?

Therapies with genes and genetically modified cells can potentially cure many major human diseases including cancer. A good example of such therapies are the new CAR-T cells therapies.

While the basic research in this field is very active, there is a bottle neck in the development of suitable clinical protocols deriving from the initial discovery. In other words, too few products enter now in the ATMPs marked in comparison with the high number of pre-clinical research projects.

We identify this bottle neck as mainly lack or resources to efficiently develop and validate a clinical protocol before entering GMP manufacturing. Costs and knowhow are the major components of the problem especially for academic research groups and small biotech companies.

What is your approach to meet the need?

We think that developing a new infrastructure to aid researchers in their process development towards GMP production is key to meet this need. Currently there are no easily available pre-GMP facilities that can be rented for a cost less than the full GMP facility. Thus, the pre-GMP facility located at KI Campus Flemingsberg on Alfred Nobels Allé 8, in the middle of a 10.000 m2 research facility offers a unique opportunity for academia and industry to work in an environment specialized for ATMP development.

This will allow the users to get in contact with the leading scientists in the ATMP field to develop their protocols and products.

How will this improve Sweden´s capabilities within ATMPs?

We believe that there is potentially a very rich environment for ATMPs in Sweden, but innovative ideas need to be supported not only in the very beginning but all the way until they are mature for clinical use. Our pre-GMP facility will be a step in the process, we will offer an affordable service that can take the innovative projects closer to actual GMP production, reducing risks and costs involved in the development and validation of new protocols. The aim is to increase the number of ATMPs trials and also products that reach the market and therefore a higher number of patients in the coming years.

For more information please contact Project Leader Matti Sällberg email

To contact facility manager Anna Pasetto