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

Aseptic processing to maintain the integrity of ancillary materials for cell therapy manufacturing

Aseptic processing is one of the most critical steps in the production of biopharmaceuticals. It is uniquely challenging in its requirements for personnel and facilities. Avoiding contamination requires careful planning, effective personnel training, attention to detail on the part of technicians, and specialized facilities and equipment. These activities, skills, and facility features are necessary to

Advancements in biomedical engineering: developing hydrogels for tissue regeneration and drug delivery

Hydrogels are a 3-D network of highly absorbent polymers that have been investigated since the late 20th century for various biomedical applications, including drug delivery, wound healing, and tissue engineering. Their highly absorbent nature gives them a flexibility similar to natural tissues and allows oxygen, nutrients, proteins, and other biomolecules to readily enter and nourish