CAMARILLO, Calif., May 1, 2024 /PRNewswire/ — PBS Biotech, a leading provider of single-use bioreactor systems and process development services, announces the successful attainment of the ISO 9001:2015 certification of its Quality Management System (QMS). This certification reflects PBS Biotech’s commitment to meet the needs of customers by maintaining effective quality standards across its operations. The ISO 9001:2015 certification will ensure that PBS Biotech’s single-use bioreactor systems are manufactured and delivered under the highest standards of quality management, significantly enhancing their reliability, robustness, and efficacy for commercial manufacturing of cell therapy products.
“Earning this ISO 9001:2015 certificate is not only a recognition of the quality of our products but also of the way we operate on a daily basis,” commented Brian Lee, Chief Executive Officer of PBS Biotech. “I feel proud of how our world-class team elevates the technology and standards for the emerging cell therapy industry.”
The ISO 9001:2015 certification is an internationally recognized standard for quality management systems. To achieve and maintain this certification, a company must demonstrate a robust system that is repeatable, measurable, and implements continuous improvement. This certification underscores PBS Biotech’s ability to consistently provide products and services that fully meet customer needs as well as statutory and regulatory requirements.
As part of the evaluation process, an independent auditor performed an on-site audit at PBS Biotech’s Camarillo-based facilities over the course of 5 days. During this time, the auditor verified PBS Biotech’s procedures and “Commitment to Quality” policy, which covers commitment to high standards, a customer and patient focus, continuous improvement, and the conviction that complying with procedures ensures quality. All executive managers and employees are committed to upholding this commitment each day.
“Achieving ISO 9001:2015 certification of our quality management system is a significant milestone for PBS Biotech,” says Scott Summersgill, Executive Director of Quality of PBS Biotech. “This shows our commitment to continuous improvement and meeting the needs and expectations of our customers, ultimately assuring them that our quality management system is designed to ensure the quality of PBS Biotech products and services.”
About PBS Biotech
PBS Biotech is a leading manufacturer of single-use bioreactor systems and provider of process development services. PBS bioreactors utilize proprietary Vertical-Wheel® technology to create homogeneous and scalable mixing conditions for a variety of sensitive cell therapy products and cell culture applications. PBS Biotech’s vision is to become the world’s standard manufacturing platform for allogeneic cell-based therapies.
For more information about PBS Biotech visit www.pbsbiotech.com.
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SOURCE PBS Biotech Inc.
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