Quality at Akron

The integrity of your drug product relies on the quality of your ancillary materials. We mitigate your risks by placing quality at the forefront of everything we do.

The Akron team continues to invest in its systems, partnering with leading providers such as TrackWise, Blue Mountain, and Labvantage to continue raising the bar.

We lead the industry in generating robust filings that provide regulatory authorities access to our products’ analytical testing procedures, characterization and release specifications, manufacturing process validations, stability programs, and other critical information while reviewing your regulatory filings. We support filings in the U.S. (FDA), Canada (Health Canada), Europe (EMA), and Japan (PMDA).

We recognize that quality involves more than best-in-class systems and global filings. It requires a commitment to industry partnership in the design and implementation of standards. We co-founded the Standards Coordinating Body and have collaborated on groundbreaking publications defining novel approaches to risk mitigation in raw material qualification.

Facility ISO Certification

Our facility is certified to ISO 13485:2016 for Manufacture of ancillary materials intended for use in the manufacture of cell and gene-therapy medicinal products for medical applications. See our facility certificate here.