Nucleus Biologics announced a complete line of cGMP grade media and a new supplement to enable improved insulin response and standardized processing of human pancreatic islets and beta cells.
In patients with Type 1 diabetes, pancreatic islets are attacked by the immune system impairing insulin production and regulation of blood glucose levels. The number of Americans diagnosed with Type 1 diabetes is expected to grow from approximately 1.3 million in 2016 to 5 million by 2025. Studying islets is fundamental to understanding how to restore insulin production. However, islets are largely quiescent and functionally deteriorate rapidly in culture. Preserving viability and function is essential for research studies and therapeutic development.
Designed for enhanced in vitro functionality of human pancreatic islets, Nucleus Biologics' new cGMP ecosystem consists of zIslet™ Factor Supplement (zIF™) and CMRL islet culture media: CMRL 1066, Supplemented; CMRL Suspension Media; and CMRL 1066 Supplemented with CIT Modifications.
The modified cGMP CMRL formulations were developed in collaboration with Dr. Elina Linetsky from the cGMP Advanced Cell and Biologic Products Manufacturing Facility, Diabetes Research Institute, University of Miami. They are based on product characterization and manufacturing standards developed at University of Miami in preparation for clinical trials at the Clinical Islet Transplant Consortium (CIT).
zIF™ is a cGMP, xeno-free albumin or serum replacement developed in collaboration with Gregory L. Szot from the Islet Production Core at the University of California, San Francisco. When used with CMRL media, zIF™ demonstrated superior islet insulin response to a glucose challenge and preservation across multiple cadaver donor islet preparations compared to human serum albumin (HSA).
"The islet community has been underserved by industry for too long due to a lack of cGMP grade products and optimized supplements. In keeping with our mission to speed the time from discovery to cure, we are delivering innovative, transparent, cGMP products that improve the quality of the islets and streamline our customers' regulatory process," said David Sheehan, Founder, President and CEO of Nucleus Biologics.