The stem cell industry is an exciting and rapidly-changing sector, so we have released new content that we are excited to share with you. Covered below is information about the upcoming September 8th Public Workshop at the FDA, as well as articles highlighting regulatory advances, new product launches, industry mergers, world firsts, and the new and emerging market for dental stem cells.
Enjoy and let me know what you think!
According to the FDA, the purpose of the public workshop is to identify and discuss scientific considerations and challenges to help inform the development of human cells, tissues, and cellular and tissue-based products (HCT/Ps) subject to premarket approval, including stem cell-based products. I got my registration confirmation this week and hope to see a ton of you there. You can get information here or register at this link.
Human stem cell-derived cardiomyocytes are particularly important for preclinical cardiac safety assessment. While several independent groups have derived human cardiomyocytes from iPSCs, there are only a few commercial providers that specialize in these cells types. Cellular Dynamics International (CDI) is the best-known American provider, while Axiogenesis has grown into a dominant European provider of these cell types. A unique attribute of Axiogenesis is that the company actively participates in validations in public consortia, such as the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative.
RoosterBio has announced the launch of a new xeno-free version of exceptionally efficient human mesenchymal stem/stromal cell (hMSC) expansion medium. This xeno-free media formulation extends RoosterBio’s portfolio of bioprocess media engineered to streamline culture processes, minimize processing time, significantly decrease production costs, reduce regulatory burden and simplify the transition into scalable platforms for clinical and commercial adult stem cell manufacturing.
Based in South Africa, Next Biosciences is a unique company. It owns Netcells, Africa’s largest private stem cell bank. It also recently merged with a local laboratory, Genesis Genetics, making Next Biosciences the only facility on the African continent to offer genetic and metabolic screening, as well as storage of umbilical cord blood and tissue. The merger of these local leaders in stem cell banking and genetic testing consolidates their position within the African biotechnology industry.
The CryoSave European flagship company was established in 2000 and operates laboratories in Switzerland, Dubai, Netherlands, Belgium, Germany, South Africa, and Portugal. As of 2016, they have processed more than 300,000 cord blood samples, the largest number in Europe. CryoSave Arabia, part of the global CryoSave network, was officially launched in 2006, by the UAE Minister of Health and now operates the region’s largest private laboratory and cryogenic preservation facility. In a world first, CryoSave Arabia announced that it has supplied the first privately stored stem cell sample released from the UAE to the United States.
Dental pulp is the soft living tissue inside a tooth that contains mesenchymal stem cells (MSCs). BioEden began offering tooth stem cell storage as early as 2006, making it one of the earliest known providers of dental stem cell storage. The National Dental Pulp Laboratory launched shortly thereafter in 2007. The dental pulp storage market is still relatively small, because of the early stage of research concerning the use of dental pulp stem cells. However, it is a growing area, as an average of 1-2 new providers are now entering the global marketplace every month.
Mesenchymal stem cells (MSCs) are one of the fastest growing areas of stem cell research. They are now more frequently cited than any other stem cell type within the scientific literature. Google Trend data also shows MSC searches to be approximately twice as common as the next most common adult stem cell type. The market for MSCs is growing. Are you informed about market opportunities and ready to act on them now?
BioInformant is the first and only market research firm to specialize in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Medical Ethics, Vogue Magazine, and more. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry data.