A historic milestone was set on June 28, 2023, when the U.S. Food and Drug Administration (FDA) granted approval for Lantidra to CellTrans, Inc., a company headquartered in Chicago, Illinois. Lantidra is a groundbreaking allogeneic pancreatic islet cellular therapy derived from the pancreatic cells of deceased donors. This landmark decision made it the world’s first cellular therapeutic to be approved for the treatment of type 1 diabetes, a disease that does not yet have a permanent treatment option. Lantridra is designed specifically for adults who have difficulty achieving target glycated hemoglobin levels due to recurring episodes of severe hypoglycemia. [Read more…]
Cell therapy manufacturing is becoming of growing importance as more and more cell therapeutics make their way through clinical trials. One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.
Cell Therapy Manufacturing CDMOs
While these realities may sound like negative factors for the industry, the reality is quite the opposite. For cell therapy CDMOs, these factors create pressures for cell therapy companies to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing. [Read more…]
Since the discovery of induced pluripotent stem cells in 2006, a great deal of basic research has been done to understand how to produce, manipulate, and utilize the stem cell type. In addition to this important basic research, a great deal of applied (“translational”) results has been done with the cell type. Induced pluripotent stem cells (also called iPS cells or iPSCs) are revolutionizing regenerative medicine because they represent a potential route for producing patient-specific stem cells for research or clinical use.
In the future, iPS cells will facilitate progress in personalized medicine by allowing a patient to use his or her own cells. In addition, iPSCs also show great promise in other areas, such as phamaco-toxicological screening, by allowing disease modeling and safety assessment of potential new drugs under development, in short, facilitating the study of a “disease in a dish.”
Can stem cell treatments for arthritis bring relief to those suffering from the disease?
From the dawn of history to present day, the swelling and aching of joints rank as one of the most troublesome indicators of age. As connective tissue breaks down over time, the result is stiffening, pain and immobility. While some are luckier than others, few seem to escape it entirely – which is why stem cell treatment for arthritis is intriguing to so many. [Read more…]
Cord blood market segmentation is one of the most important (and least appreciated) parts of analyzing the cord blood banking industry. As the first and only market research firm to track the stem cell industry, BioInformant has collected over 16 years of historical information on the cord blood industry from 2006 to present. This provides a powerful record if past industry dynamics, as well as a robust platform for making future projections. [Read more…]