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
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
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?
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
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
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
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
