Data Beyond Temperature: Digital Integration Of The Supply Chain Boosts Support Of Advanced Therapy Products

By Kevin O'Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc.

The White House 2012 National Bioeconomy Blueprint forecasts that increased cell manufacturing research activities would lead not only to significant improvements in public health, but also provide tremendous economic benefits to the next generation of biotechnologies. Predictably, groundbreaking techniques to elevate quality assurance, increase efficacy, enable production scale-up, and reduce manufacturing and product cost of requisite bioprocesses are needed to support the long-term growth of the regenerative medicine industry.

To this end, the Georgia Research Alliance, in conjunction with Georgia Institute of Technology and the National Institute of Standards and Technology (NIST), have formed the Cell Manufacturing Consortium (CMC). Member participants are leading the development of a regenerative medicine industry roadmap whose aim is to provide a pathway to overcome cell manufacturing, storage, an transportation challenges and capitalize on opportunities that will maintain the United States’ position at the head of the rapidly expanding global regenerative medicine industry. Currently 52% of the world’s leading companies investing in this technology are headquartered in the U.S.

In the wake of such growth, the Cell Manufacturing Consortium has identified and prioritized a variety of research and development activities that the cell manufacturing industry must pursue to help maintain and advance and advance the United States’ lead in the global cell manufacturing industry.