reNEW Copenhagen enters collaboration with the Cellerator
Associate Professor Agnete Kirkeby and PhD student Alison Salvador from her lab at reNEW Copenhagen are developing a therapy for the treatment of dementia. They are currently testing their developed stem cell product through implantation into rat brains.
Developing a novel therapy and bringing it into the clinic is a long and complex process that can take several years. One of the key steps in this process is to produce the cells for clinical use under good manufacturing practices (GMP). GMP guidelines ensure that therapies are produced in a controlled and consistent way to meet high-quality standards and to guarantee their safety before they can be used in clinical trials. This process helps minimise the risk of contamination or errors that could affect the treatment’s effectiveness or harm patients. In this way, manufacturers can ensure that every batch of therapy meets the same high level of quality, which is crucial for both patient safety and regulatory approval.
The Cellerator, a Novo Nordisk Foundation initiative that aims to close the gap between successful stem cell research in the lab and effective therapy treatments for patients worldwide, has expertise in process development to product GMP manufacturing. The Cellerator and the research group of Associate Professor Agnete Kirkeby have now entered a collaboration to prepare a GMP manufacturing protocol for their stem cell product for dementia.
‘We are very excited to start this collaboration with the Cellerator, as they can provide important expertise, which we don't have in our academic lab,’ says Kirkeby.
The collaboration involves guidance on choosing the right reagents which are GMP compatible, what the product needs to be tested for, and what equipment to use so the team can be well-prepared for when they go to the GMP facility to produce their product.
‘I'm certain this collaboration can speed up translation towards the clinic,’ she adds.
The Cellerator is further also working with other stem cell groups to develop and manufacture cell products consistently and at a scale for entering early clinical trials.