Akron Biotech is committed to help defeat COVID-19 – Together we cure Coronavirus disease 2019 (COVID-19) is a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptoms tend to appear 2-14 days after exposure to the virus and can range from mild to severe, with some patients requiring hospitalization1. In response to this
The disruption to daily life from our collective preventative measures against the global SARS-CoV-2 outbreak is obvious to most. Many industries are being held back and we will likely see long-term or permanent effects from the shifts happening with social interaction in and out of the workplace. What may not be so obvious in the
In the burgeoning cell and gene therapy market, companies at all stages of pre-clinical and clinical development are faced with a similar set of challenges of producing effective, standardized, and compliant therapies. The novelty of these technologies combined with the rigorous quality controls surrounding the materials and production process require a specialized approach for starting
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
Ancillary materials play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that these therapies cannot be sterilized, ancillary material quality is critical to clinical advancement and commercialization. At Akron, we believe that a harmonized definition of what constitutes
Clinical trials occur in phases – Phase I through Phase III – and if successful, culminate in FDA approval to market a drug product. In the US, Phase III trials generally assess if a new treatment method or drug product is as effective or better than existing treatments or products. In short, Phase III trials
The field of immunometabolism has attracted growing attention in recent years due to the high potential for the development of cancer immunotherapies. Upon activation, T lymphocytes (T cells) undergo significant metabolic changes that allow them to mediate immune responses. Stimulating these and other immune cells has important outcomes beyond energy production (Fig. 1). A key
Akron recently participated in the Alliance for Regenerative Medicine (ARM) Cell & Gene Meeting on the Mesa, joining hundreds of the largest companies in the cell and gene therapy space to discuss progress to date and foster a shared vision for the future of regenerative medicine. Panels covered themes including the impact of Brexit on
The advancement of cell therapies depends on the success of industry-wide efforts to reduce variability in source materials, manufacturing processes, and analytical strategies. A newly-published paper in Regenerative Engineering and Translational Medicine identifies several sources of variability throughout the cell therapy supply chain, manufacturing process, and release testing, and identifies standardization efforts, automation strategies, and
As Autumn quickly approaches and conference season begins, the Akron Biotech team is preparing to participate in several events showcasing talks by leading industry experts and exhibitions spanning the cell, gene and biotech therapeutic industries. These events offer a great opportunity for Akron to better understand our clients’ challenges, global regulatory directives and how our
