UK-based Abzena has unveiled its EpiScreen 2.0, a next-generation immunogenicity assessment tool to check the development of complex biologics and bioconjugates.

EpiScreen 2.0 is an upgraded bioassay platform designed to enhance the prediction and assessment of potential immunogenic risks in preclinical stages of protein, antibody, and gene therapy therapeutics.

Abzena said that the advanced tool represents the next generation of immunogenicity assessment that is more sensitive, multi-parametric, and data-rich.

The results refine candidate selection and minimise risks during early-phase development.

Abzena, an end-to-end integrated contract development and manufacturing organization (CDMO) specialises in complex biologics and bioconjugates.

Abzena initially launched the first generation EpiScreen platform over 20 years ago, laying the groundwork for advancements in the immunogenicity field.

EpiScreen 2.0 represents a significant evolution, providing an expanded repertoire of immune response metrics with enhanced sensitivity.

It generates detailed insights into specificity and mechanism-of-action (MoA), empowering developers to understand immunogenicity profiles.

Additionally, the tool adopts strategic measures such as protein engineering and formulation to mitigate risks.

Using flow cytometry, the Time Course Assay within EpiScreen 2.0 achieves sensitivity levels comparable to conventional assays employing [3H]-thymidine for proliferation measurement.

Abzena said the methodology enables the characterisation of immune cell responses through multiplexed readouts incorporating cell activation markers.

Furthermore, the platform facilitates the evaluation of diverse immune cell types, including CD8+ T-cells, giving insight into the MoA, useful for gene therapy.

These data-rich assays cater to a spectrum of drug modalities, including biologics, bioconjugates, and gene therapies.

In addition, it can be used as a standardised platform method or tailored to individual programmes.

Abzena chief scientific officer Campbell Bunce said: “We developed EpiScreen 2.0 because we understand that there are many factors that contribute to the immunogenicity risk of a drug, especially with the next-generation therapeutics being developed like Antibody-drug conjugates (ADCs).

“I’m not aware of any other service provider that offers such an extensive set of immunogenicity assessment capabilities covering bioinformatics, proteomics, and ex vivo human immune cell assays underpinned by a high-throughput, high-quality infrastructure for blood processing and storage.”

In February, the CDMO launched its new analytical platform, LabZient, to reduce drug development timelines and resource expenditures.