Akston Biosciences Corporation is developing affordable, innovative medicines for everyone, everywhere in the world. It is led by the team at SmartCells, Inc. that developed SmartInsulin and sold it to Merck & Co. in one of the largest preclinical pharmaceutical acquisitions in history.
While a great financial success, the team later saw how a big pharma’s slow and risk-averse approach to developing this break-through therapeutic kept the world’s first glucose-responsive insulin from reaching the people who need it most.
With that in mind, it built Akston to bring innovative new biologics through the riskiest development phases, faster, more cost- effectively, and with a higher likelihood of success by:
- Owning the key development and manufacturing infrastructure. Akston designed and built a multi-kilogram-scale GMP biologics factory, with full Process Development and Quality Control capabilities, all under a Quality Management System.
- Using a common platform for all candidates. Each of its products is derived from the Ambifect™ Fc-fusion protein platform, leveraging common manufacturing and analytical processes to speed development and reduce regulatory risk.
- Building deep partnerships. Akston licenses its candidates to go-to-market partners, but also maintains close involvement with those partners in the product development process.
This model is well-suited for biologics development today, but will become even more valuable as U.S. payors, especially the federal government, force a reduction in the lifetime returns for innovative biologics.
Akston has built a strong pipeline. It has licensed its COVID-19 vaccine to Biolexis, a Strides Group Company, and has also licensed two once-a-week veterinary insulins to Dechra Pharmaceuticals, PLC. The company has active development programs in human insulin, Type 1 diabetes prevention, and oncology.
Akston has built its development infrastructure and pipeline with less than $45M in equity investment, much of it from the executive team and former SmartCells stockholders, and $10M from National Institutes of Health grants and The Helmsley Charitable Trust.
Akston operates over 18,000 square feet of GMP manufacturing and laboratory space in its Beverly, Massachusetts facility. This includes a multi-kilogram-scale, GMP biologics factory with a production-scale Process Development facility and a Quality Control (QC) laboratory, all under a Quality Management System (QMS). The 7,500 square foot cleanroom facility is used for production of GMP drug substance, uses single-use processing equipment, and supports the clinical and commercial development of Akston’s therapeutics. It includes an ISO7/Grade C cleanroom for inoculation, an ISO8/Grade D cleanroom for up- and down-stream processing, and an ISO8/Grade D cleanroom for post-viral processing.
Akston also operates a Good Laboratory Practices (GLP) lab for analyzing clinical samples and a research laboratory that is used to process, purify, and formulate therapeutic candidates for in vivo testing. The research laboratory includes a rodent vivarium and analytical testing equipment for in-house studies.