Partnership on TCR Affinity Measurement Services Announced by Quality Assistance and Immudex

Quality Assistance and Immudex are pleased to announce that they have entered into a partnership providing services to the pharmaceutical industry, in particular the measurement of T cell receptor (TCR) affinity.

Quality Assistance is a leading analytical CRO that provides a complete range of analytical services in a GMP environment including surface plasmon resonance (SPR) assays and biolayer interferometry (BLI) assays.

Immudex has expertise in manufacturing soluble TCR Monomers and TCR Dextramer^® reagents that undergo rigorous quality control to confirm specificity and functionality. Immudex also has over 10 years’ experience in manufacturing high quality peptide-MHC (pMHC) monomers.

Using Immudex’s pMHC and TCR Monomers, Quality Assistance has established reliable assays to determine the affinity and kinetics of the interaction between TCRs and pMHC complexes.

Through this partnership, Immudex and Quality Assistance offer TCR affinity measurement services to clients within the pharmaceutical industry. This enables, for example, determination of the dissociation constant (Kd) and investigation of the specificity of the TCR:pMHC interaction by evaluating the interaction with a cognate pMHC compared to an off-target pMHC.

Henrik Pfundheller, CCO of Immudex, comments “TCR affinity is an important consideration in developing a successful T cell therapy, hence there is a growing need for reliable assays to understand TCR affinity. We are pleased to partner with Quality Assistance to enable companies to outsource measurement of the affinity of their candidate TCRs to a reliable service partner using our high quality TCR and pMHC Monomers.”

Arnaud Delobel, R&D and Innovation Director at Quality Assistance, comments “In our collaboration with Immudex, Quality Assistance leverages its expertise in analytical development and cutting-edge technologies like SPR and BLI to measure TCR affinity. Accurate TCR affinity measurement plays a pivotal role for companies involved in the development of T cell-based immunotherapies.”.

Further Information

Quality Assistance provides the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. Its experts design customised solutions, define analytical protocols, as well as develop and validate specific new analytical methods, in order to evaluate the Quality, Safety and Efficacy of the given drugs for each client project.

TCR Monomers and TCR Dextramer^® reagents are available from Immudex’s Custom Solutions and Services department. Immudex has successfully produced a broad range of TCRs and specificities, including native TCRs, affinity-optimized TCRs, and model TCRs e.g. NY-ESO-1. Immudex also offers a broad portfolio of pMHC Monomers including MHC I and II, MR1, CD1d, HLA-E, HLA-G, as well as custom alleles.

About Immudex

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.

About Quality Assistance

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

Quality Assistance holds a unique place on the market with all of its laboratories on one site in Belgium, 250 highly-qualified professionals and more than 40 years’ expertise at the forefront of analytical sciences.

The company assists its clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. Quality Assistance designs customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.