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

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

The challenge of raw material variability and strategies for standardization

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

Driving Innovation & Lowering Cost of Goods through Improved Customer Management

At Akron, our Customer Relationship Management (CRM) system is more than just a database; it’s an adaptive framework that informs our developments and iterates based on our clients’ needs, just like our Quality Management System (QMS). The ideal CRM process focuses on the interactions between a business and its customers, with the principal goals of