BOCA RATON, FL — The regenerative medicine industry experienced tremendous growth in 2017. With the FDA’s new policy framework in place, as well as the approval of two cell therapies and endorsement of another, the industry is primed to continue its rapid climb into 2018 and beyond. Akron’s progress to date, and plans moving forward, are a testament to that. Here are some highlights from the past year:
In June 2017, Akron CEO Claudia Zylberberg co-chaired a meeting with the National Academies of Sciences, Engineering, and Medicine and the Regenerative Medicine Forum focused on cell therapy manufacturing. Participants discussed the main challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. Leading up to the workshop, Dr. Zylberberg co-authored a paper titled “Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century.”
This year, we released four publications and received two grants, highlighting our commitment to discovery and innovation. Through our research and development department and our strong relationships with academic partners, we strive to solve challenging problems. Some of our key academic partners include Stanford University and the Worcester Polytechnic Institute. Furthermore, Akron served as a marketing case study for EMBA students at the Wharton School, University of Pennsylvania.
Akron was delighted to join two of the new, federally-funded Manufacturing Innovation Institutes: the Advanced Regenerative Manufacturing Institute (ARMI) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). These organizations are dedicated to accelerating innovation in manufacturing within the regenerative medicine industry. Akron is also coordinating efforts to create a Florida Institute for Regenerative Medicine, in collaboration with key research, clinical, and industrial partners in the state. In addition, Akron is leading efforts to drive industry growth and consolidation through the development of industry standards as a co-founder of the Standards Coordinating Body (SCB) and a leader on various ISO standards under development.
Akron was represented at numerous conferences, including Phacilitate’s Cell & Gene Therapy World, the International Society of Cell Therapy (ISCT) annual meeting, the Alliance of Regenerative Medicine Meeting on the Mesa, the BioFlorida Annual Meeting, the American Association of Blood Banks (AABB) annual meeting, the Organ Preservation Alliance Organ Banking Summit, the Tissue Engineering and Regenerative Medicine International Society (TERMIS) meeting, the International Society for Stem Cell Research (ISSCR) meeting, and the American Society of Cell & Gene Therapy (ASGCT) meeting.
We launched two new products (M26 and IL-2 liquid syringe) and invested in a significant expansion of our existing facilities. At our Boca Raton headquarters, we doubled our office space and tripled our laboratory and cleanroom footprint. With this increase in installed capacity, we are poised to remain a leading driver of growth in the burgeoning regenerative medicine industry.
With the boom in the cell and gene therapy industries, we significantly expanded our clientele as a supplier of key cGMP ancillary materials, a purveyor of technical services, and as a contractor for products and services ranging from custom media to sterile-fill/finish to scaffold electrospinning. Our ancillary materials and reagents have been utilized in FDA-approved cell therapies, marking Akron’s ability to provide high-quality materials and services from the benchtop to clinical trials to market.
Thank you to our collaborators, partners, and clients for a productive year. Together, we have set a solid foundation for growth – and we look forward to working with you in 2018 and beyond.
Akron is an innovative company dedicated to the development, manufacture, and marketing of ancillary materials and novel products/tools under cGMP compliance for tissue, cell and gene therapies, serving the regenerative medicine industry from bench to bedside.