ARM Member Profiles

We offer “Critical Quality Attribute (CQA) ID” and “cell culture medium optimizations services” to cell therapy and CDMOs as follows.

1. CQA Exploration Services
In recent years, regulatory agencies have increasingly demanded detailed data on batch-to-batch variations and equivalency of cell products intended for clinical use. Additionally, some cases have emerged where statistical efficacy could not be sufficiently demonstrated in post-marketing surveillance, leading to waiver in full approval despite of obtaining conditional approval. Our company performs single-cell transcriptome comparative analysis of cell batches that showed efficacy in preclinical and clinical trials versus those that did not. This analysis identifies the composition and state (gene expression) of cell populations, leading to the identification of efficacy indicators.

Our single-cell transcriptome analysis is highly regarded for its world-leading gene detection count and accuracy, achieved through the removal of dead cells and doublets by flow cytometry, as well as capturing mRNA using our proprietary cDNA preparation technology (Nature Biotechnology, 2020). We excel in analyzing tissue or cells with low mRNA content. Our technology captures 30%-50% of all expressed genes, compared to only 7%-23% captured by competing technologies like Dropseq.

2. Culture Environment Optimization Services
Once the critical quality attributes (CQA) for regenerative or cell therapy products are defined, the next challenge is to consistently cultivate cells that meet these criteria.

We create and culture cells in thousands of types of cell culture media in-house, combining various concentrations of cytokines, vitamins, amino acids, nucleic acids, lipids, heavy metals that are found in our body. The cultured cells are then analyzed through AI by integrating time-lapse images of cells, growth of cells, transcriptomes, and other omics data, identifying the optimal media components and cell culture environments that consistently meet the CQA.
The optimized media can be provided under cGMP conditions from us, and of course we can accommodate creating serum-free media.