CAMBRIDGE, England, April 25,
2024 /PRNewswire/ -- Abzena, the leading end-to-end
integrated CDMO for complex biologics and bioconjugates, has
announced the launch of its enhanced bioassay platform EpiScreen®
2.0, a comprehensive suite of assays that predict and evaluate
potential risks of preclinical immunogenicity in protein, antibody,
and gene therapy therapeutics. The next generation tool provides a
better immunogenic assessment that is highly sensitive,
multi-parametric, and data-rich, which ultimately improves
candidate selection and de-risks early phase development.
Abzena launched its first generation EpiScreen® platform over 20
years ago and are considered to be innovators in the field of
immunogenicity. The newly enhanced EpiScreen® 2.0 builds upon the
original platform by delivering a more advanced set of immune
response measurements with the required sensitivity, plus detailed
information on specificity and mechanism-of-action (MoA) to better
inform the nature of immunogenicity risk and how to mitigate this
through protein engineering and formulation.
Using flow cytometry, EpiScreen® 2.0's Time Course Assay
delivers levels of sensitivity comparable to traditional assays
using [3H]-thymidine as a readout for proliferation and allows
characterization of the responding immune cells by multiplexing the
readout with cell activation markers. Beyond the standard
assessment of CD4+ T cells, the platform can evaluate the responses
of other immune cells, including CD8+ T-cells, giving insight into
the MoA, which can be useful for gene therapy, where evaluation of
the endogenous antigen processing pathway is more
relevant.
These data-rich assays can support an array of drug types
including biologics, bioconjugates, and gene therapies, and can be
delivered as a platform method or customized to each program to
provide the necessary information needed to select the best
candidate for clinical evaluation.
Dr Campbell Bunce, CSO of Abzena said, "Understanding a lead
drug candidate's immunogenicity risk profile and how we can
mitigate it is a key step in advancing new drugs from discovery to
clinical trials. 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. Our EpiScreen® 2.0 platform allows drug developers to
be better informed and more confident in progressing to later stage
development with a better chance of success in patients."
About Abzena
Abzena is the leading end-to-end
bioconjugate and complex biologics CDMO + CRO. From discovery
through commercial launch, we support customers with fully
integrated programs or individual services designed to de-risk and
streamline the development of new treatments for patients in need.
With the ability to tailor its strategy and customer experience to
each project, Abzena develops and implements innovative solutions
that enable biotech and biopharma companies to realize the full
potential of their molecule and move medicines forward faster. The
company has research, development, and cGMP facilities across
locations in San Diego, CA,
Bristol, PA, and Cambridge, UK. Abzena is owned by Welsh,
Carson, Anderson & Stowe, one of the world's leading private
equity investors. Learn more at abzena.com.
View original
content:https://www.prnewswire.com/news-releases/abzena-launches-episcreen-2-0--a-next-generation-immunogenicity-tool-for-de-risking-the-development-of-complex-biologics-and-bioconjugates-302127919.html
SOURCE Abzena