CAMBRIDGE, England and SAN DIEGO, Nov. 19,
2024 /PRNewswire/ -- Abzena, the leading
end-to-end integrated CDMO + CRO for complex biologics and
bioconjugates, announced the expansion of their early and
late-phase analytical capabilities to now include GMP cell-based
potency assays at their Cambridge,
UK and San Diego, CA
development and manufacturing facilities. The expansion enhances
Abzena's extensive bioassay offering, providing customers with a
more comprehensive, streamlined, and cost-effective way to access
critical data faster.
GMP cell-based potency assays play an essential role in
quantitatively measuring the biological activity of a
biopharmaceutical, and the cytotoxicity of the payload of an
Antibody-drug conjugate (ADC), for both GMP product release and
stability testing. By adding this capability to their global
toolkit, Abzena will be able to provide precise and reliable data
on drug potency, alongside developability and characterization data
including mechanism of action (MOA) and immunogenicity, which are
essential for regulatory submissions.
Dr Campbell Bunce, CSO and Cambridge Site Head at Abzena said,
"We recognize that high-quality data is the cornerstone of
effective decision-making. When it comes to early-phase
biopharmaceutical programs, especially ADCs, developers must have a
reliable CRO partner with the deep knowledge and technical
capabilities required, and who can deliver the necessary data
needed to successfully reach their next target inflection
point."
"Our established expertise and reputation have allowed us to
extend our early-phase capabilities to include GMP cell-based
potency services at our global sites, addressing a critical need
for our customers. This significant milestone further demonstrates
our commitment to providing comprehensive, end-to-end support for
our customer's next-generation programs that drive successful
outcomes from discovery to the clinic and onwards towards
commercial."
Sean O'Brien, SVP & San Diego
Site Head at Abzena shared, "Biological drug development requires
robust analytical support across all phases of development. At
Abzena, we've placed significant importance on building a
state-of-the-art analytical toolkit because we understand the value
that it provides to our customers."
"Our goal is to help our customers optimize their drug
development strategies, secure funding, and navigate regulatory
pathways more effectively. We will continue to invest in our
expertise and expand our laboratories so that our broader
analytical offering can best support them in their mission to get
life-changing medicines to patients."
All the Cambridge, UK site's
services are fully integrated with Abzena's development and
manufacturing services at their US facilities in San Diego, CA, and Bristol, PA.
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.
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