#United States #Newark #ACROBiosystems #Innovation Lab #ISO 17025

ACROBiosystems' US Innovation Lab Achieves ISO 17025 Accreditation

In a significant advancement for biomedicine, ACROBiosystems' U.S. Innovation Lab has recently been awarded ISO/IEC 17025 accreditation. This recognition affirms the lab’s proficiency in providing Surface Plasmon Resonance (SPR) analytical services, and underscores its capability to generate reliable and consistent results, esteemed on an international level.

ISO/IEC 17025 is a globally recognized standard that outlines the requirements for testing and calibration laboratories. It encompasses crucial factors such as equipment and reference materials, metrological traceability and calibration, methods for testing and calibration, and the management of samples. This accreditation not only strengthens the lab’s operational capacity but also enhances stakeholder trust in its outputs across the globe.

SPR is instrumental in the biopharmaceutical industry, enabling real-time analysis of biomolecular interactions without the need for labeling. Its applications span drug screening, studying protein-protein interactions, examining antibody-antigen binding, and performing kinetic and affinity analyses—essential components throughout the drug development process, from initial discovery to final product characterization and quality control. The attainment of ISO/IEC 17025 ensures that ACROBiosystems' SPR analytical service is both competent and reliable, with results acknowledged worldwide.

Comprehensive Services Offered by ACROBiosystems

The SPR Analytical services offered by ACROBiosystems form a part of a broader array of laboratory capabilities which include Analytical Services, Custom Reagent Services, and Assay Development Services. These offerings present a cohesive toolkit for clients throughout the biological drug development pathway—covering everything from complete process solutions for antibody drugs, fusion proteins, and cell and gene therapies to vaccines and diagnostic kits. To date, ACROBiosystems has successfully completed over 1,500 projects for more than 500 clients globally, contributing to crucial regulatory approvals and commercialization pathways such as INDs, NDAs, and BLAs.

Commitment to Quality Management

Since its inception, ACROBiosystems has focused on augmenting its quality management systems, achieving certifications such as ISO 9001 and ISO 13485. The establishment of a GMP-grade product quality management system further affirms its commitment to maintain superior quality. The organization also holds the MDSAP certification alongside the recent ISO 17025 accreditation, reflecting its dedication to adhere to high international standards. The professional quality management team possesses a wealth of experience in navigating global biomedical regulations, thus facilitating prompt modifications of the quality system to cater to various product categories, customer expectations, and regulatory mandates.

About ACROBiosystems Group

Founded in 2010 and publicly listed in 2021, ACROBiosystems is a pioneering biotechnology firm that plays a vital role in the global biopharmaceutical and health sectors through inventive product solutions and business models. With a strong global foothold, including offices and R&D centers in cities across the United States, Switzerland, England, and Germany, the company collaborates with leading pharmaceutical giants like Pfizer and Novartis, as well as esteemed academic institutions. The ACROBiosystems umbrella includes several subsidiaries, such as bioSeedin, Condense Capital, and ACRODiagnostics, all dedicated to providing high-quality recombinant proteins, kits, antibodies, scientific services, and supplementary products, strictly adhering to their robust quality control processes for utilization in biopharmaceutical R&D, production, and clinical applications.

With a steadfast goal of expediently advancing drug development, including targeted therapies and immunotherapeutics, ACROBiosystems is contributing significantly to the global health landscape.