The UTS Biologics Innovation Facility (BIF) proudly announces its ISO 9001 certification, which covers a broad range of technical capabilities and services, including training, education, contract research, and facility hire in biologic drug manufacturing. This certification underscores the BIF’s commitment to global quality management standards and confirms its pivotal role in Australia’s fast-growing biomanufacturing ecosystem.
ISO 9001, issued by the International Organisation for Standardisation (ISO), is the world's most recognized quality management standard. It provides a robust framework for ensuring consistent quality in products and services through thorough process assessments, with a focus on continuous improvement, customer satisfaction, and regulatory compliance.
As a unique hub for academic and industry collaboration, the BIF offers services in bioprocess development and scale-up, along with immersive hands-on training in a GMP-like environment. The facility is equipped with tissue culture cabinets, bioreactors, chromatography and filtration systems, and QC tools, supporting the pilot-scale production of biological products such as antibodies, RNA technologies, viral vectors, cell therapies, and cellular agriculture products.
David Rickards, BIF Manager who led the certification process, highlighted the significance of this achievement:
Gaining ISO 9001 certification reflects the hard work and commitment of the entire BIF team to quality and excellence. We are thrilled to offer our services to Australia’s biomanufacturing industry with the assurance of an ISO 9001 accredited quality management system.
With this new accreditation in place, the BIF will continue to provide the highest quality bioprocessing services to its trainees, collaborators, and clients.