The National Institute of Biological Standards and Control (NIBSC) is partnering with ReNeuron to develop novel techniques, based on Next Generation Sequencing (NGS), that can assure the quality and safety of new cellular therapies entering the market.
With funding from Innovate UK’s medicine and manufacturing challenge fund, this collaboration will support the regulation and use of next generation advanced therapies that offer new hope for many incurable diseases.
Current advances in stem cell research rely on the use in vitro based assays including flow cytometry and immunocytochemistry, to characterise new cell-based therapies.
Whilst these methods can provide a wealth of information about the cells, they’re unable to provide a complete picture of the cells present within the population, or predict how the cell therapy will perform when used in patients.
Ultimately as these cells are intended for use in humans, without answers to these questions it’s hard for researchers to assure quality control and provide confidence to a regulator or eventual patient that the manufactured therapy is safe and effective.
Supported by Innovate UK’s medicine and manufacturing fund, the project aims to use powerful new single cell transcriptomics technology to create a new set of reference data to facilitate the introduction of innovative therapies and address concerns on the quality and safety of new cell-based therapies.
With new sequencing techniques becoming more affordable and more reliable, it’s expected these methods will have a growing role to play in assuring the safety of biological medicines in future.Jack Price, Head of the Division of Advanced Therapies at NIBSC comments:“Cell therapies have the potential to revolutionise medicine and greatly impact on public health but there are still hurdles to overcome so we can assure regulators and patients of their safety, particularly on a large scale.”