As quality standards in the iPSC industry continue to rise, Stem Genomics is strengthening its product and service standards to best meet the evolving needs of its customers.
The cornerstone of this strategy has been the recruitment of a Quality Manager, Emmanuelle VULCAIN, whose main task is to guide the team along this challenging path. She explains what she means by “quality” in the context of the iPSC field.
I’m here to lead the Stem Genomics team on a journey of continuous improvement with a collective and dynamic state of mind. Fortunately, the work had already started before I arrived and I was pleasantly surprised to find that the ISO 9001 standards were well embedded in the company culture. Everyone here is motivated by achieving high standards of quality and this gives me great satisfaction, as I believe that “quality is everyone’s responsibility”, to quote the famous W. Edwards Deming.
Understanding the needs and expectations of our customers is paramount in my work. Scientists working with iPSCs have several constraints: to meet regulatory standards from the FDA or EMA, with robust QC to ensure a safe end product, but they also need to ensure an acceptable final cost of the manufactured therapy.
In the field of cell therapy, most companies have great science but many struggle at the manufacturing stage. This can lead to failure at the feasibility stage. We therefore need to closely follow our customers’ needs in order to help them succeed. Quality control assays, such as the iCS-digital™ range that we consider to be our flagship offering in genomic stability testing, are a great combination of performance and cost-effectiveness that have been supporting our most demanding customers since 2018.
The field is still relatively immature compared to other segments of cell therapy (e.g. CAR-T) and we need to anticipate scientists’ future needs to help them succeed. We cannot stand still as it is moving fast. The encouraging trials of companies such as Bluerock/Bayer with Bemdaneprocel, Vertex with VX-880 or Sana with their allogeneic islets show that a breakthrough is imminent. We try to comply with recognized standards such as the ISSCR Standards for the Use of Human Stem Cells in Research, and we regularly consult with regulators to anticipate what the future holds. We are working hard to be one of the companies that helps scientists succeed. Ultimately, if we do our job properly, they will be able to focus on their research and deliver therapies faster.
Source:
¹Alliance for Regenerative Medicine – Investment Sector Data (Q1 2024, analysis as of April 2024)
² iPSC Clinical trials landscape, M. Makhloufi, Treefrog therapeutics.
