Immudex Announces ISO 13485 Certification to Support the Manufacturing of Clinical-Grade Dextramer® (GMP) Reagents
Immudex is proud to announce the ISO 13485 certification of its manufacturing facility for Dextramer® reagents in Virum, Denmark, demonstrating that these are manufactured in compliance with strict international standards.
The ISO 13485 certification supports the manufacturing of Immudex’s Clinical-Grade Dextramer® (GMP) reagents, analyte-specific reagents (ASR) in the US, and the Dextramer® CMV Kit (IVD), which is available for in vitro diagnostic use in the EU and the US.
Quality is one of Immudex’s core company values. We believe that our responsibility for manufacturing clinical-grade reagents does not end there. We have therefore worked to establish and operate our Quality Management System (QMS) to ensure that all our products are of the highest quality, from production to product release and during use.
ISO 13485 certification is the result of the continuing efforts of our employees, demonstrating that they are committed to quality processes and quality products. This certification confirms that our QMS conforms to ISO 13485, providing a high degree of certainty for scientists using our Clinical-Grade Dextramer® (GMP) products in clinical trials, for the manufacturing and quality control of investigational and commercial pharmaceutical products, or as components in laboratory-developed tests (LTD).
Henrik Pfundheller, CCO of Immudex, comments “we have observed a growing demand for Clinical-Grade Dextramer® (GMP) reagents as pharmaceutical companies adopt a wide range of therapeutic strategies to modulate the T-cell response, from CAR-T cells to TCR-T cells, dendritic-cell vaccines, and soluble TCR therapeutics, addressing diseases from cancer to autoimmune and infectious disease. We are pleased to support these efforts with Clinical-Grade Dextramer® (GMP) reagents for release testing and precision immune monitoring.”
Liselotte Brix, CSO of Immudex, notes that “the scientific community is realizing precise measurement of antigen-specific T-cell responses is a crucial part of the immune response. We support that scientists are calling for the FDA to recommend T-cell assessment in COVID-19 vaccine trials, as this will be critical for evaluating vaccine efficacy.”
Clinical-Grade Dextramer® (GMP) reagents are used in the GMP manufacturing of cell-based immunotherapeutics, to ensure that they meet the required lot release criteria, and to monitor antigen-specific T cells following therapeutic intervention.
ISO 13485 is an international standard which defines the quality system requirements for medical devices where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements.
Immudex Clinical-Grade Dextramer® (GMP) reagents are manufactured following good manufacturing practice (GMP), and meet numerous criteria in accordance with quality system requirements for medical devices defined by ISO 13485 and FDA 21 CFR 820.
Download Immudex’s ISO 13485 certificate here.
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Immudex ApS is a pioneering life science company and the trusted partner of scientists worldwide spearheading the global adoption of precision cellular immune monitoring. Immudex’s mission is to help researchers and clinicians unravel the complexity of the immune system, enabling the development of more effective immune-based therapeutics and diagnostics.
Immudex operates globally, with headquarters in Copenhagen, Denmark, and North American operations based in Fairfax, Virginia. Immudex’s Dextramer® technology is superior for the detection of antigen-specific immune cells, including rare and low-affinity cells. Immudex offers a broad product portfolio that allows scientists to investigate diverse types of immune cells, including T cells, non-conventional T cells and B cells, with reagents tailored to specific applications. Immudex’s products are compatible with multiple platforms from flow cytometry to next generation sequencing and single-cell multi-omics.
In addition to Dextramer® reagents for basic research, Immudex also provides Clinical-Grade Dextramer® (GMP) products and Dextramer® CMV Kits (IVD) manufactured in ISO 13485:2106-certified facilities, according to the requirements of FDA QSR 21 CFR 820. Immudex’s products enable scientists to get the full picture of the immune response, supporting ground-breaking advances within immuno-oncology, transplantation, autoimmune and infectious diseases. Find out more at www.immudex.com.