Newsroom

Akron Biotech submits eCTD Drug Master File for IL-2 with the FDA

New, more comprehensive electronic format to provide transparency and comparability support for advanced therapy developers

Boca Raton, Florida, February 13, 2019 – Akron Biotechnology, a leading supplier of ancillary materials to the regenerative medicine industry, announces that it has filed a Drug Master File (DMF) Type II for its Interleukin-2 (IL-2) in Electronic Common Technical Document (eCTD) format with the U.S. Food and Drug Administration (FDA).

Akron has long supported its customer base through DMF filings and therefore elected to update its IL-2 filing to the new electronic format in an effort to provide the more detailed and comprehensive information required by advanced therapy developers for their regulatory filings.

“As cell and gene therapy products expand into more complex target indications, it is increasingly important to manufacture with the highest quality materials, while gaining the maximum amount of visibility into the composition of those materials,” said Claudia Zylberberg, CEO of Akron Biotech. “These improvements will enable cell and gene therapy products to reach market, and therefore patients, more quickly, increasing their overall chance of clinical success.”

Akron is among the first in the industry to file an eCTD DMF for IL-2, a critical ancillary material in the production of cell-based immunotherapies. This advancement will have a broad-ranging impact for both research and commercial aspects of the market.

“It was important for Akron to be one of the first companies to supply IL-2 products with the additional data and documentation required by the eCTD format as we see our customers as partners on the journey towards commercial development,” Zylberberg added.

A significant part of developing and producing high-quality and compliant advanced therapies is the use of higher-grade ancillary materials and the security of supply of those materials. DMFs are essential for sponsors in that they verify the quality of ancillary materials, assuring developers that their production processes are scalable and consistent.

Referencing the highest quality DMFs has become a valuable strategy for developers to reduce the workload associated with material qualification, thereby accelerating approvals. A number of companies supplied by Akron have already referenced Akron DMFs in their regulatory filings.

About Akron Biotechnology

Akron Biotechnology is a leading supplier to the regenerative medicine industry. Akron develops and manufactures cGMP-compliant ancillary materials and provides specialized services in order to accelerate the clinical development and commercialization of advanced therapies. For more information, please visit us at www.akronbiotech.com.

Contact Information:

Image Box PR

Neil Hunter / Michelle Boxall

Tel +44 (0)20 8943 4685

neil@imageboxpr.co.uk / michelle@imageboxpr.co.uk

BOCA RATON, Fla. – Akron Biotechnology has partnered with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the Texas A&M Engineering Experiment Station (TEES) to pursue an exciting workforce development initiative.

TEES leads the grant, which combines online and in-person modules to train technicians on processes required in biotherapeutics manufacturing. Developed and delivered by TEES’ National Center for Therapeutics Manufacturing (NCTM), the curriculum includes upstream bioreactor operation, downstream processing, and analytical testing. As part of its commitment to professional development, Akron has enrolled two manufacturing team members in the training.

NCTM’s Director Dr. Zivko Nikolov shared, “We are honored by NIIMBL’s sponsorship and proud to collaborate with Akron through this rigorous educational program that will immerse participants in more than 100 hours of cGMP bioprocess training. Upon completion of the program, more than forty technically skilled graduates will be ready for immediate employment with NIIMBL partner companies.”

“Akron Biotechnology is dedicated to continuing education and workforce development,” said Claudia Zylberberg, CEO of Akron Biotechnology. “The biopharmaceutical industry is rapidly evolving, and it is critical that training be aligned with industry needs. We are excited to partner with NIIMBL as well as the academic and industry team members on these initiatives.”

“NIIMBL invests in projects that will strengthen the pipeline of skilled workers for the biopharmaceutical industry. This project promises a robust curriculum that will serve industrial needs,” said John Balchunas, NIIMBL Workforce Director.

About Akron Biotechnology
Akron Biotech is a leading supplier to the regenerative medicine industry. We develop and manufacture cGMP-compliant ancillary materials and provide specialized services in order to accelerate the clinical development and commercialization of advanced therapies. For more information, please visit us at www.akronbiotech.com.

About NIIMBL
NIIMBL is a public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing. NIIMBL is part of Manufacturing USA®, a network of 14 manufacturing institutes across the country that brings together industry, academia, and the public sector to propel promising research developments, accelerate new products to market, and train tomorrow’s workforce in order to secure America’s future. NIIMBL is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina, and the Commonwealth of Massachusetts. The NIIMBL mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.

About the Texas A&M Engineering Experiment Station
As an engineering research agency of Texas, TEES performs quality research driven by world problems; strengthens and expands the state’s workforce through educational partnerships and training; and develops and transfers technology to industry. TEES partners with academic institutions, governmental agencies, industries and communities to solve problems to help improve the quality of life, promote economic development and enhance educational systems.

Download this announcement here.

BOCA RATON, Fla. – Akron Biotechnology has partnered with Marsha Rolle, associate professor of biomedical engineering at Worcester Polytechnic Institute (WPI), to develop a novel cryopreservation media to support the storage and transport of manufactured tissues. The project, funded by the Advanced Regenerative Manufacturing Institute (ARMI), a Manufacturing USA Institute headquartered in Manchester, N.H., furthers the mission to enable the large-scale manufacturing of engineered tissues and tissue-related technologies.

Specifically, Rolle and Akron will develop dimethyl sulfoxide (DMSO) – free cryopreservation media. DMSO has long been used as a cryoprotective agent for cells and tissues, but it is known to be cytotoxic, alter cell behavior, and have negative clinical side effects. Thus, there is a need to seek novel, alternative solutions.

“The cryopreservation market is growing rapidly as new cell and tissue therapies reach clinical use. These innovative products are needed to keep up with the growing demands for high quality cryopreservation media. Just as new cryopreservation solutions are needed, so too are the testing platforms to evaluate their efficacy,” said Dr. Claudia Zylberberg, CEO of Florida-based Akron Biotechnology.

This collaboration combines Akron Biotechnology’s strengths in the commercial cryopreservation media market with Dr. Rolle’s lab expertise at WPI in engineering and evaluating tissue constructs that can serve as a testbed for novel preservation strategies.

“We are eager to partner with Akron to develop innovative approaches to functional screening of tissue cryomedia,” said Rolle. “Technologies that enable preservation of tissue structure and function will be critical to enable transport, availability, and clinical efficacy of manufactured tissues.” Zylberberg echoed Rolle’s comments.

“We are very excited about our strategic partnership with WPI to further the development of cryopreservation media to serve the expanding tissue engineering and regenerative medicine (TERM) industry,” continued Zylberberg. “ARMI has been an excellent catalyst in bringing together diverse sets of skills from industry and academia to forge new connections. As the TERM field continues to grow, it is essential that we bring together the right experts in order to continue driving innovation.”

About Akron Biotechnology
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. For more information, please visit https://www.akronbiotech.com/

About the Advanced Regenerative Manufacturing Institute (ARMI)
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org

About Worcester Polytechnic Institute
WPI, a global leader in project-based learning, is a distinctive, top-tier technological university founded in 1865 on the principle that students learn most effectively by applying the theory learned in the classroom to the practice of solving real-world problems. Recognized by the National Academy of Engineering with the 2016 Bernard M. Gordon Prize for Innovation in Engineering and Technology Education, WPI’s pioneering project-based curriculum engages undergraduates in solving important scientific, technological, and societal problems throughout their education and at more than 45 project centers around the world. WPI offers more than 50 bachelor’s, master’s, and doctoral degree programs across 14 academic departments in science, engineering, technology, business, the social sciences, and the humanities and arts. Its faculty and students pursue groundbreaking research to meet ongoing challenges in health and biotechnology; robotics and the internet of things; advanced materials and manufacturing; cyber, data, and security systems; learning science; and more. WPI is a participating member in eight Manufacturing USA institutes. www.wpi.edu

Download this announcement here.

Press release from ARM Foundation for Cell & Gene Medicine

CONTACT: Mariesa Kemble
+1 (608) 850-4745
kemblem@mac.com

ARM Foundation for Cell and Gene Medicine Announces Board of Directors Appointments

Experts in regenerative medicine bring exceptional leadership to ARM Foundation to help increase understanding and acceptance of cell and gene medicine.

Washington, D.C., August 14, 2018 – The ARM Foundation for Cell & Gene Medicine (ARM Foundation), an independent 501(c)(3) non-profit organization, today announced five appointments to its Board of Directors: Amy DuRoss of Vineti; Brett Kopelan of debra of America; David Nagler, formerly of Audentes; Frank Sasinowski, M.S., M.P.H., J.D. of Hyman, Phelps and McNamara and Claudia Zylberberg of Akron Biotech.

The appointees will work with ARM Foundation Board Members and its leadership team to deliver on the organization’s mission of providing education and research that will accelerate patient access to safe, efficacious and potentially curative cell and gene therapies, tissue-engineered products and organ regeneration.

“We are honored that these experienced leaders in the cell and gene medicine community will lend their expertise to the important work of the ARM Foundation,” said Stewart Parker, chair of the ARM Foundation Board of Directors. “Each of them brings a unique perspective, deep commitment and enthusiasm to engage, inform, and empower the public and other stakeholders on key scientific, clinical, and regulatory issues that affect the advancement and acceptance of cell and gene medicines as viable and transformative treatment options.”

The newly appointed Board members will also serve on steering committees that will guide the ARM Foundation’s initial projects including a gene medicine education program; an in-depth impact analysis of cell and gene therapies and other regenerative medicines on national and international healthcare economies; and research to identify and prioritize the infrastructure, logistics, and healthcare system requirements for wide-scale adoption of transformative medicines.

About the ARM Foundation for Cell and Gene Medicine (ARM Foundation)
The ARM Foundation for Cell and Gene Medicine is an independent, 501(c)(3) non-profit organization dedicated to providing education and research that will accelerate patient access to safe, efficacious and potentially curative therapies. Its programs engage, educate and empower patients, caregivers, industry leaders and other stakeholders to help advance the science and benefits of gene therapy, gene editing, cell therapy, tissue-engineering and organ regeneration. By increasing understanding and acceptance of these transformative technologies, the Foundation hopes to involve more people in the clinical trial process and therefore help expedite the development of life-saving therapies. To learn more, visit http://www.thearmfoundation.org.

Download this announcement here.

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.

ABOUT AKRON
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.

Download this announcement here.