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
A Note to Our Valued Partners Regarding COVID-19 As we continue to deal with the challenges and uncertainty of Covid-19 Virus, our priority is to ensure the safety of our employees while minimizing any potential impact to our valued customers and partners. Therefore, we are taking all the necessary precautions to ensure that our
A Letter From Our CEO Dear Valued Partner, In challenging and uncertain times, it’s our collective responsibility to take care of one another. At Akron Biotech, our top priority is always our customers and our staff. That’s why we are closely monitoring the COVID-19 situation around the clock, ensuring that we take all necessary precautions
On January 20, Akron Biotech CEO Dr. Claudia Zylberberg will launch an updated version of her children’s book, You’re Full of Genes, during the Future of Medicine Day at the Philip and Patricia Frost Museum of Science in Miami, Florida. The book, an updated version of her 2001 original by the same title, takes children
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 regenerative medicine is rapidly expanding due to the regulatory approval of breakthrough cell and gene therapy treatments. It is imperative now more than ever to keep patient safety in mind. For this reason, the industry has been shifting towards the use of animal-derived component free (ADCF) materials. Ancillary materials (AMs) are utilized
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
