Boca Raton, FL, US, April 7, 2021 – Akron Biotech, a leading developer and manufacturer of cGMP-compliant ancillary materials for cell and gene therapy development and commercialization, today announces the appointment of a new Scientific Advisory Board. The board is comprised of world-leading scientists and experts in the cell and gene therapy field. It will
Reducing Variability in Cytokine Activity Reporting
Ensuring the quality and consistency of ancillary materials used in the manufacture of cell and gene therapies is critical to both controlling costs and ensuring the integrity of the therapeutic product. It is our responsibility as ancillary material manufacturers to reduce the variability that biomanufacturing presents. This is especially important when considering the manufacture of
Safety First: Methods of virus inactivation for increased safety of advanced therapies
Regulatory agencies around the world have been steadily increasing pressure on cell, gene, and tissue-engineered drug development companies to put safety first and find ways to control the inherent risks present in many of the raw materials used in the downstream processing of their advanced therapies. The industry has been largely transitioning away from animal-derived
A new year, a new perspective
What a year it has been…We started by wishing everyone a year of vision: 20/20 is perfect sight, technically speaking. As it turns out, perhaps this wasn’t referring to a year of vision in terms of individual and collective achievements, but of vision for solutions and a new perspective in a new era forming before
Cryopreservation During the Holidays
As the holidays approach, tissue and cell labs around the globe have to start thinking about cryopreservation. This critical procedure can be overwhelming: What media should I use? What type of cryoprotectant is optimal for my cell type? What is the appropriate freezing rate? At what temperature is plunging appropriate? How about adequate thawing rates?
Building a resilient cell and gene therapy industry in the face of COVID-19
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
The importance of cytokine and growth factor purity in cell therapy development and manufacturing
Today, it is more important than ever to understand the quality of ancillary materials in the cell and gene therapy supply chain. As part of a therapy developer’s risk and impact assessment, each material must be evaluated for purity, lot-to-lot consistency, and potential impact on the drug product. Because of its outsized impact on cost
You’re full of genes! Akron CEO Claudia Zylberberg launches a children’s book on genetics
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
Join us in Orlando and Amsterdam this week as we present our staged approach to cGMP ancillary materials
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
Superiority, Non-inferiority and Equivalence – The Phase III Question
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