Designer immune cells to assess drug safety, potency, and efficacy

To meet the ever-increasing demand for immune cells and immune cell preparations, biomedical researchers are exploring alternative ways of obtaining immune cells by means of novel bioprocesses, as well as methods for propagating such cells. A team of researchers led by Prof. Nico Lachmann is making use of the capacity of induced pluripotent stem cells (iPSCs) to continuously divide and differentiate. They have successfully produced mature immune cells, such as macrophages, in scalable systems, i.e. from laboratory scale to industrial application.

This method of standardized immune cell production is very helpful for investigating and evaluating candidate drugs, whose safety and efficacy can thus be tested directly in human target structures. The aim is to advance the development and validation of these tests under the Fraunhofer Attract program in the project “IMMUNITY – designer cells: novel immune cell platforms for health research”. In addition, it is planned to establish cell-based potency assays measuring the biologic activity of biologics and bioengineered drugs. Such assays play an important role in GMP quality control and release testing of active pharmaceutical ingredients and medicinal products. Based on this key technology for continuous production of macrophages from iPSCs, the researchers also want to develop novel manufacturing processes for different fully standardized immune cell products and cell-based immunotherapies. The Fraunhofer Attract project will be funded with 2.5 million euros over a period of five years.