Highlights of the ISCT, London, 3-6 May 2017
2017 is the 25th Anniversary of the International Society for Cellular Therapy (ISCT)
Its Annual Meeting attracted this year more than 1500 delegates globally who participated at 4 days of top-notch presentations, interesting debates and interactive workshops.
We have listed for you the Highlights:
qPCR Mycoplasma testing is winning from the traditional culture or colorimetric methods: increased interest in cell therapy because of the enhanced sensitivity and rapid turn around time.
- Europe, US and Japanese pharma permit PCR assays for detection of mycoplasma and the regulators accept the alternative method from the compendial tests.
- Validation expectations are defined under EP section 2.6.7.
- CFU/GC ratio must be determined to be sure the pharmacopeial standards are met
Rapid detection of bacterial contamination in cellular products:
Sterility testing is a critical component of release testing for any cellular product. The current compendial testing takes 14 days before contamination can be ruled out with certainty. Due to the short time lines in batch release in cell therapy, there is a need for growth-independent rapid microbiology testing. In order to enhance sensitivity and reduce time-to-result, qPCR techniques will be needed to overcome these limitations (poster Nesemann et al, Sartorius).
Main focus CAR T-cells next to the Memory T-cells:
CAR T-cells are very much on the foreground, however TCR (T-cell receptor) edited memory stem T-cells are maybe the “one cell to yield them all”, being tumor specific T-cells. The core of this approach is to edit TCRs of patients T-cells with tumor specific TCR genes.
Commercialization of cell therapy products:
The poster from Delphi G.M. showed a study investigating the decision-making and argumentation for non-marketing authorization of ATMP’s in the EU: while many clinical trials with ATMP’s have been performed in Europe, currently only 15 marketing authorization applications have been submitted. They give an overview of the major objections and which aspects play a crucial role in regulatory decision-making.
In the presentation of Kurt Gunter “Barriers to successful development of cellular therapies: what can be done to overcome them?”, it was mentioned that only 10% of the cell products will make it.
General take home message: while during previous years most topics at ISCT involved MSC’s , today cancer immunotherapy has clearly taken the lead. The fundamentals behind this are the significant scientific breakthroughs in recent years, with CART-cells, engineered TCR’s , checkpoint inhibitors at the forefront. Probably the combination of different therapies, offering synergistic effects, will be the future, e.g. additional therapy after relapse and combination with antibody drug therapy.