Florida Biologix Enters Manufacturing Agreement with America Stem Cell
Florida Biologix (Alachua, FL) has signed a development and manufacturing contract with America Stem Cell (Helotes, TX) for a Phase 1 cell therapy product, ASC-101. ASC-101 is a human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells.
Florida Biologix (Alachua, FL) has signed a development and manufacturing contract with America Stem Cell (Helotes, TX) for a Phase 1 cell therapy product, ASC-101. ASC-101 is a human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells.
ASC-101 has been proven to accelerate hematopoietic and immune system recovery, reducing the treatment-related mortality rate associated with infections during the patient’s immune-compromised period. ASC-101 also may enable adult cancer patients requiring bone marrow transplants to be treated quickly with cord-blood derived stem cells from a single cord blood unit, avoiding the long and often-futile wait for matching bone marrow or peripheral-blood derived stem cells.
Florida Biologix will conduct process and assay development, an engineering run, final cGMP manufacturing, and purification of the enzyme. The company also will conduct a formulation and fill-and-finish of the substrate that will be used, along with the enzyme, for the Phase 1 clinical trial targeted to start at University of Texas MD Anderson Cancer Center in early 2010.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
