by akronbiotech

What a year it has been at Akron!

We’ve continued to raise the bar, focusing on what matters most – enabling the development and commercialization of tomorrow’s cures. We’ve done this by securing the supply of critical GMP materials for our customers, the institutions and companies leading the way.

This has been a big year for us in so many ways. We’ve expanded our team, enhanced our manufacturing and analytical capabilities, and streamlined our operations through the implementation of SAP, all to ensure that we can continue to support the industry’s accelerated growth.

We’ve doubled down on the promise of immunotherapy, leveraging our large scale GMP cytokine manufacturing capacity – including our flagship aldesleukin (IL-2) as well as our IL-7, IL-15, and IL-21 – to drive the development of promising technologies. We have also heeded the FDA’s call for greater compliance and transparency in the realm of ancillary materials, submitting several comprehensive eCTD Drug Master Files, with several more to come in 2020. This speaks to our enduring commitment to de-risking the cell and gene therapy supply chain.

Our website has been revamped in several ways. First, we have built out our services pages to include the comprehensive list of custom development and manufacturing capabilities that Akron offers. Second, we now provide a comprehensive overview of the importance of incorporating high-quality ancillary materials into advanced therapy manufacturing protocols, and explain Akron’s quality principles and practices. This becomes especially important as so many therapies inch closer and closer to market approval and commercialization. We must ensure patient safety above all else.

We are proud to have established and grown new and existing relationships with leading academic and clinical research centers around the world, validating our commitment to helping build these therapies from the ground up. Innovation is in our DNA, so you will see several new products launched in the coming year. As with all of Akron’s new products, our pipeline focuses on filling critical gaps to help novel therapies reach patients in a fast and cost-effective manner.

We remain committed to helping our customers navigate the relationship between quality and costs. Indeed, we have published extensively on both of these topics this year. We have contributed to collaborative efforts in Allogeneic CAR T cost modelling, variability in cell therapy manufacturing, and cell preservation strategies. More publications on these themes are slated for next year.

In very exciting news, we just published our GMP stages for ancillary materials, a scheme that provides safety, security, and transparency to therapy developers and clinical trial sponsors. We believe that this scheme can inform the next ISO standard for ancillary materials. Akron has been a key driver of these standardization efforts in the past, and will continue to be a voice for greater standardization and harmonization in the industry’s supply base, which is critical to the industry’s continued growth.

We continue to be active members of various consortia such as the Advanced Regenerative Manufacturing Institute and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), as well as key industry bodies like the Standards Coordinating Body (SCB), the Alliance for Regenerative Medicine Foundation (ARMF), the International Society for Cell & Gene Therapy (ISCT), as well as other entities as part of our commitment to building the industry.

Beyond industry leadership, Akron remains committed to education at all levels. On January 20th, 2020, we will be launching a revised edition of the children’s book, “You’re Full of Genes.” All proceeds will be allocated to foundations in the space. For curious readers, students, and industry representatives, our bi-weekly blog provides a view into Akron. Posts are drafted by members of every department, offering a comprehensive view of what we do, and what matters most to us. We participate in webinars and public meetings for the same reasons – to talk about what we do, as well as how and why we do it.

Last, but certainly not least, this year brought us an incredible new partner. With Arcline’s acquisition of Akron, we have the opportunity to continue scaling our business the Akron way – with a singular focus on providing our customers the highest quality materials possible at the scale they need. Our success is their success. We are very excited about what this new relationship brings to Akron. Arcline brings a great group of smart and seasoned people, who are just as committed to the industry and to the community as we are.

We have a lot to be thankful for. The list of our team’s accomplishments is too long to capture here. But I wanted to give you all a sense for what we have been up to. Stay tuned for 2020. A year in sharp focus.

Happy holidays, and enjoy the last few days of the year. Take the time and space to recharge for a great year ahead.

Claudia



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