Quality

Cell and gene therapies are highly complex biological systems whose manufacture requires the use of specialized ancillary materials. The integrity of an advanced therapy depends on tight upstream control measures; including the use of high-quality ancillary materials.

At Akron Biotech, our aim is to bring top quality ancillary materials into your process as early as possible so that you can avoid redeveloping your process, requalifying your ancillary materials, or performing unnecessary bridging studies later on.

How to think about compliance in the realm of ancillary materials. Find out more about nomenclature, standards, and best practices for risk-based approaches to ancillary material qualification.

Akron has long participated in collaborative standards development efforts, participating in discussions, whitepapers, and publications aimed at formalizing quality standards for ancillary materials. Learn more about our work.

What do we mean when we say “cGMP”? Akron has decades of experience in the development and production of cGMP compliant ancillary materials and clinical-grade biologics. Learn more about what we do to ensure the safety of your advanced therapies.

Advanced therapies cannot be sterilized. We believe that your therapy is as good as the ancillary materials you use to produce it. Find out why an early commitment to quality in your ancillary materials is critical to long-term success.