APR Sept/Oct 2023 - 87

« FACILITY TOUR
available. Services supporting In-Use clinical and compatibility studies
as well as GLP test article characterization are also offered.
According to Nathan Whitford, Eurofins BPT Columbia President,
" Our site works closely with our partners to design client-specific
validation and stability programs. With an industry leading integrated
laboratory information management system (LIMS), we provide
not only expertise in testing but also seamless delivery of accurate
data to our clients through secure electronic portals in real time
via LabAccess.com. Additionally, the ability to partner with other
global Eurofins BPT locations offers a tremendous advantage for us
and value to our clients and their global supply chains. " Eurofins BPT
Columbia continues to be a client-focused service provider with the
facility, instrumentation, and expertise to address the evolving needs
of the biopharmaceutical industry.
Eurofins BPT Columbia's Response
to the Global Pandemic
The Columbia site provided key analytical testing support for a major
COVID-19 vaccine manufacturer during the pandemic. Loretta Sukhu,
Director of Operations, noted, " Our success in pivoting to become the
North American testing site for one of the COVID vaccines was due
to our capability to leverage our technical expertise in bioassays, cell
and molecular biology, and biochemistry. Previous investments in key
instrumentation with redundancies meant that product testing could
be executed without delay. " A key contributor to the success of this
program was a newly implemented 5S LEAN initiative, which ensured
good management and control of lab supplies and materials. Affiliates
in the worldwide Eurofins network of laboratories came together to
share materials and supplies to support this work.
Similar to other North American EBPT sites, the Columbia team
validated methods and conducted release and long-term vaccine
stability studies to support Emergency Use Authorization and IND
submissions. The site also conducted batch release and stability studies
to ensure product efficacy and safety. Comprehensive studies using
quantitative and endpoint PCR, cell-based recombinant viral vaccine
assays, ELISAs, spectroscopy, RP-HPLC, dynamic light scattering,
protein fingerprinting, and monograph testing were completed to
ensure product identity, potency, purity, and safety.
Efforts to minimize viral transmission within the facility, while at the
same time maintaining near normal operations, was also a challenge
during the pandemic. To ensure the safety of employees and their
families, the site implemented zoning strategies and alternate work
schedules. This flexibility ensured success in achieving 5-day identity
and 10-day potency testing required by the client's need for rapid
product release.
Whitford adds, " Looking back, our success was largely due to the
resiliency of our team, the depth of their experience, and their desire to
make a difference during one of the most challenging times in recent
history. Combining this with our strong client partnerships and their
commitment to patients aligns well with our mission to contribute to
a safer and healthier world. "
Challenges Facing the Cell and
Gene Therapy Industry
There are currently 32 FDA approved cell and gene therapy (CGT)
treatments.1
Although the development of this class of drugs is still
extremely customized, highly complex, and very expensive, the
therapeutic benefits are indisputable. While the market is still in its
infancy, it is rapidly growing with estimates that the global CGT market
will surpass $93.78 billion by 2030.2
Because CGTs are produced in living cells and may contain genetic and
other biological material foreign to the patient, testing of these drugs
poses a unique set of challenges. Accurate determination of product
purity and residual contaminants from the manufacturing process are
essential testing components in the development of all drugs, and
CGTs are no exception. In addition, CGTs require additional bioassaybased
analyses to ensure adequate and specific drug delivery to target
tissues. Additional methods must also be developed to assess vector
and transgene immunogenicity and potential off target specificity. A
thorough understanding of testing parameters, the development of
highly robust testing methods and compliance with evolving cell and
gene therapy regulatory guidelines also presents challenges during
the development of CGTs.
To address these challenges Eurofins BPT Columbia employs their
well-established expertise in cell-based functional and biochemical
assays and protein chemistry. Although the specific methodologies
in use are product-specific, product purity and the presence of
degradants have been quantified by biochemical techniques. The
presence of residual contaminants, such as host cell DNA and proteins
or excipients, are determined by molecular, immunological, and
biochemical techniques. Characterization of transgene expression,
including infectivity titer, gene expression in target and off target cells,
cytokine production, apoptosis, and antibody dependent cytotoxicity
evaluations have been done at Eurofins BPT Columbia via quantitative
PCR, electrophoretic techniques (including capillary electrophoresis),
size exclusion chromatography, cell culture assays, ELISAs, particle
sizing, and mass spectrometry.
The CGT testing services offered by Eurofins BPT Columbia have been
strengthened by recent capital investments in key instrumentation.
In addition to end point and quantitative PCR offerings, Droplet
Digital PCR (ddPCR) is available to provide the ultrasensitive and
absolute nucleic acid quantifications needed by CGT applications.
A state-of-the-art flow cytometer is also available to support clients
who need to multiplex up to 13 individual targets in a single sample
and a Bac-T rapid microbial identification system to support sample
testing requiring quick turnaround times. Additional instruments
include an analytical ultracentrifuge for characterizing viral particles,
as well as instrumentation to determine the physical properties of
large macromolecules using SEC-MALS. As previously discussed, the
Columbia site is equipped with full peptide mapping, protein purity,
and identity determination capabilities.
Regulatory guidance to ensure product safety and quality requires
the accurate qualification of all custom components, matrices, and
www.americanpharmaceuticalreview.com |
| 87
»
http://www.LabAccess.com http://www.americanpharmaceuticalreview.com
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
