A National Roadmap To Cell-based Therapeutics

In the past decade, new and emergent cell-based medical technologies have been developed to manage and potentially cure many conditions and diseases. In 2012 alone, such technologies treated more than 160,000 patients.

But before these treatments can be more widely available, cell therapeutics science will have to develop the capability for advanced, large-scale manufacturing of high-quality and consistent living cells.

Now, an industry consortium has created a national roadmap intended to lay out the path to large-scale manufacturing of cell-based therapeutics for use in a broad range of illnesses including blood and vision disorders, cancer, neuro-degenerative diseases, and organ regeneration and repair.

Greg Russotti, Ph.D., vice-president of technical operations for Celgene Cellular Therapeutics, said:

“The cell manufacturing roadmap effort is mission critical to establish the United States as the world leader in cell therapy manufacturing. Cell therapies offer exciting next-generation opportunities that may help patients live longer and better lives, reduce the burden on health care and benefit society.

Producing sufficient quantities of high quality cell therapies so that patients have access will not be possible without significant advances in the field of cell therapy manufacturing. Industrial, academic, and government stakeholders collaborated to construct this roadmap, which delineates our path to U.S. leadership in the emerging field of cell therapy production.”

microfluidic device

Close-up view of a microfluidic device that exploits the differences in adhesion strength between derived stem cells and contaminating cell types in a heterogeneous culture to selectively isolate cells of interest using fluid shear forces. Georgia Tech researchers designed the technique to separate the cells. Credit: Gary Meek

The Georgia Research Alliance (GRA) and the Georgia Institute of Technology (Georgia Tech) launched the National Cell Manufacturing Consortium (NCMC), an industry-academic-government partnership that recently released the National Roadmap for Advanced Cell Manufacturing. Establishment of the consortium and development of this 10-year national roadmap was sponsored by the National Institute of Standards and Technology (NIST).

While research has demonstrated the value of cell therapies, using adult stem cells and immune system cells, improvements are needed to make these cells broadly available to the medical community.

Krishnendu Roy, Robert A. Milton Chair and professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, said:

“The aspirin you buy today from one pharmacy is essentially the same as the aspirin you buy from another pharmacy, but cell-based therapies may have different efficacy depending on the source and manufacturing processes. There are established ways to quickly assess the efficacy and safety of small-molecule drugs that are acceptable around the world. We want to develop and establish similar processes for therapeutic cell manufacturing.”

For more information on the National Cell Manufacturing Consortium and to view the roadmap, visit cellmanufacturingusa.org

Top Image: adult human fibroblast cells with intracellular proteins involved in adhesion of these cells to an extracellular matrix. Magenta represents actin stress fibers in a cell and green staining represents a focal adhesion protein vinculin, which together contribute to how strongly these cells adhere to a matrix surface. Blue is the nucleus of a cell. These fibroblasts are converted to human induced pluripotent stem cells through a reprogramming process during which restructuring of the adhesion proteins takes place. Credit: Ankur Singh