The cord blood industry came into existence in the early 1990’s with the formation of several cord blood banks in the U.S. and worldwide. It has been 40 years since it was first proposed that stem and progenitor cells were present in human cord blood. [Read more…]
CryoHoldco is a stem cell bank holding company that is the market leader in Latin America and one of the top 10 largest cord blood banks in the world. CryoHoldco is now seven times larger than any other stem cell bank in Latin America with over 275,000 stem cell units in storage.
As an increasing number of stem cell therapies advance through clinical trials, the healthcare industry’s focus comes to looking at which cells, allogeneic or autologous, are more likely to be commercially feasible. Proving safety and efficacy for a specific indication is a large enough challenge for any treatment, but for stem cell therapies in particular, commercial viability may be just as big a hurdle.
Israel-based Pluristem Therapeutics (NASDAQ:PSTI), may be the only stem cell company that can mass produce immune-privileged allogeneic cells at a scale and price that not only makes them commercially viable, but moreover makes stem cell therapy a preferred method of treatment for patients and payors alike. A proprietary 3D stem cell expansion technology which uses placental-derived cells is the key. [Read more…]
Over the past few years, the regulatory landscape for cell therapy development has grown increasingly complex. There are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea. While the possibility for accelerated commercialization has resulted from these changes, substantial complexity has also been introduced, making it a more elaborate process to move cell therapy products from “bench to bedside.”
In the interview with Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics, we get an expert’s perspective on how the regulatory environment has changed and new opportunities that exist for bringing cell therapy products through the clinical trial process and into the global marketplace. [Read more…]
Founded by Dr. Jon Rowley, RoosterBio is a privately held stem cell tools and technology company focused on accelerating the development of a sustainable regenerative medicine industry. Its products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. I had the honor of interviewing Dr. Jon Rowley, who is now the CTO of RoosterBio.
In this interview, we explore RoosterBio’s recent product launches, collaborations, achievements and future trajectory. [Read more…]