Building on decades of experience manufacturing cGMP-compliant, clinical-grade materials, we are now a leading supplier of ancillary materials to the regenerative medicine industry.
At Akron, we have long sought to articulate the importance of adopting high-quality ancillary materials early in the development process, as these are critical to the development of high-quality, compliant, and scalable therapies.
How do we ensure quality? At Akron Biotech, our quality principles are at the heart of our operations.
- Operating at the highest level. Our operational practices and procedures are controlled by an industry-leading ISO 13485:2016 compliant quality management system (QMS) – the most stringent tier of manufacturing quality systems
- Manufacturing at scale. Using a single lot for months or even years significantly reduces variability in your raw material supply, de-risking your supply chain and supporting compliance with your drug product’s quality specification. In addition, this practice minimizes the burden of material qualification.
- Focusing on cGMP and clinical-grade products.
- Embodying the principles of ISO 13485, we aim to manufacture all our products according to cGMP guidelines
- Our Argentinian manufacturing site follows Pharmaceutical Inspection Convention Scheme (PIC/S) quality standards (https://www.picscheme.org/), and is frequently audited by the local health care authority, ANMAT.
- Maintaining qualified controlled environments. Our manufacturing suites are compliant with ISO 5 and ISO 7 cleanroom standards, and are qualified for pharmaceutical-grade production and sterile fill & finish activities
- Investing in our people. Our staff are trained regularly and to a high degree of competence so that we can effectively maintain and exceed our quality standards.
- Practicing what we preach. We source only the highest available grade of upstream materials for use in our manufacturing processes
- Driving continuous improvement. We are constantly developing and improving our manufacturing processes and practices to further advance quality, reproducibility, and traceability while reduce costs. Through our deep understanding of industry needs, we also work to optimize formulations and packaging.
What is ISO 13485 and why is it important?
ISO 13485 embodies the application of general standard ISO 9001 to manufacturing active implantable medical devices. ISO covers all areas of the company’s operations, including: development, production, storage, and distribution of products. Akron Biotech’s QMS was registered ISO 13485:2016 in November 2015 by BSI Group America Inc. Our manufacturing facility in Boca Raton was successfully audited for ISO 13485:2016 compliance in October 2018.
Why is ISO 13485 preferable to ISO 9001?
We have observed first-hand the limitations of ISO 9001-compliant quality systems, seeing materials manufactured under such systems become contaminated or otherwise failing to meet specifications. These failures introduce waste and inefficiency, undermine confidence in the quality system, and may adversely affect your product, potentially compromising clinical outcomes. By going one step further and implementing a medical device-grade quality system, we consistently produce high quality materials that you can have full confidence in.
Can I audit your facilities?
Clients are encouraged to visit our manufacturing site in Boca Raton, Florida, where we offer virtual audits of all our manufacturing sites from a single facility. We can provide access to a virtual documentation room, where you can meet our quality teams across the world, review our documentation and processing procedures, materials testing programs, and reports of past audits. This allows you to audit the production processes and manufacturing environments for all materials you are interested in, no matter which of our sites manufactures the specific products you are interested in. Contact us for further information.