Innovation at Akron
At Akron, we work closely with industry partners and leading academic institutions to create new products and services that enable the clinical and commercial development of next-generation therapies. We engage in targeted exploration to develop solutions to complex challenges, drive process optimization to improve efficiency and bring down costs, and implement risk mitigation strategies to support the safety and integrity of the advanced therapy.
Adapted from Utterback, James M., and William J. Abernathy. “A dynamic model of process and product innovation.” Omega 3.6 (1975): 639-656.
We always begin with a problem in search of a solution – a challenge too big for our existing technologies to bridge. We work closely with our partners to design and execute applied research projects that ultimately generate new and innovative technologies.
How do we preserve engineered tissues in a way that enables their effective delivery? This remains one of the key technological challenges facing the tissue engineering industry. We are working closely with our partners at the Worcester Polytechnic Institute (WPI) on a project funded by the Advanced Regenerative Manufacturing Institute (ARMI) that aims to develop novel cryopreservation solutions for tissue constructs. Together, we are testing and optimizing various candidates on tissue rings – modular building blocks for the construction of engineered blood vessels – to identify the most effective non-DMSO-based solutions for safe and effective tissue preservation.
Once we have developed a novel technology, we begin optimizing and scaling the manufacturing process. We recognize that to enable the clinical and commercial success of advanced therapies, we must do our part to ensure process integrity and drive down cost of goods.
We are working closely with an industrial collaborator to develop an efficient process for producing a novel therapeutic agent. We began by establishing a stable, optimized E.coli cell line to express the desired protein, and then created a cell bank for the selected clone. We then streamlined our standard operating procedures for upstream development, and then worked to optimize the downstream purification protocol. We then developed and validated the analytical assay protocol to verify protein purity, structure, bioactivity, and endotoxin levels. Finally, we generated comprehensive documentation covering the manufacturing and testing processes, thereby enabling technology transfer to third parties for production. Learn more about how we can support your protein development efforts.
Once the problem has been identified and a solution developed, we focus on de-risking these materials. An advanced therapy cannot be sterilized. Therefore, we must ensure that all materials used to develop these cell-based products are reliably and certifiably sterile and safe.
Human fibronectin is an extracellular matrix glycoprotein that plays a critical role in advanced therapy development, modulating cell adhesion and migration. Given that this product is derived from human plasma, problems with the source material, improper handling, and poorly controlled manufacturing processes can introduce a significant risk of contamination downstream. We developed our Viral-Inactivated cGMP Human Fibronectin to give you the assurance you need when sourcing this critical culture component.