03 December 2024 | Tuesday | News
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ACROBiosystems' US Innovation Lab has recently achieved ISO/IEC 17025 accreditation for its Surface Plasmon Resonance (SPR) analytical service, ensuring that results from this service is globally recognized and trusted for its precision and consistency.
ISO/IEC 17025, an international standard for the operation of testing and calibration laboratories, are a series of guidelines that emphasizes equipment and reference materials, metrological traceability and calibration, calibration and testing methods, and sample management— all of which is critical for assessing a laboratory's calibration or testing capabilities. This accreditation bolsters the lab's operational capabilities and enhances trust in its work both domestically and internationally.
SPR is a vital tool in biopharmaceutical drug development, offering real-time analysis of biomolecular interactions without labeling. It plays a crucial role in drug screening, understanding protein-protein interactions, assessing antibody-antigen binding, and kinetic and affinity analysis throughout the drug development chain, from early discovery to late-stage product characterization and quality control. Thus, the ISO/IEC 17025 standard ensures the competence and reliability of their SPR analytical service, with its results being recognized globally.
ACROBiosystems' Innovation Lab Services
ACROBiosystems' Innovation Lab's SPR Analytical Service is part of a suite of offerings that integrate Analytical Services, Custom Reagent Services, and Assay Development Services. The lab provides a unified and versatile set of services throughout the biological drug development process, including full-process solutions for antibody drugs, fusion proteins, cell and gene therapies, vaccines, and diagnostic kits. ACROBiosystems has completed over 1,500 projects for more than 500 customers worldwide, aiding in regulatory approval and commercialization processes such as IND, NDAs, or BLAs.
ACROBiosystems Group's Quality Management System
Since its establishment, ACROBiosystems Group has been enhancing its quality system, passing ISO 9001, ISO 13485, and establishing a GMP-grade product quality management system. It has also passed MDSAP and ISO 17025. The company's professional quality management team, with extensive experience, is well-versed in global biomedical regulations, enabling rapid adjustments to the quality management system to meet diverse product types, customer needs, and regulatory requirements.
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