Charles River and PathoQuest Announce Publication of a Head-to-Head Study Validating Proprietary Next Generation Sequencing Viral Safety Assay as a Reliable In Vitro Alternative to Animal Testing Methods
06 Setembro 2023 - 9:00AM
Business Wire
NGS assay demonstrated a broader detection
range than standard in vivo tests with comparable or higher
analytical sensitivity
Charles River Laboratories International, Inc. (NYSE: CRL) and
PathoQuest SAS, a leader in the development and provision of
next-generation sequencing (NGS) testing services for
biopharmaceuticals, today announced the publication of the results
of a seminal study in Vaccine. This unique study demonstrated that
PathoQuest’s proprietary, good manufacturing practice (GMP) grade
NGS-based assay had a greater capability of detecting viral
contaminants when compared to in vivo assays.
While the classical approach to testing for viral contaminants
in biologics includes animal- and egg- based methods, the long
turnaround time, limits in the ability of current methods to detect
viruses, and increased demand for in vitro testing are major
concerns for the pharmaceutical industry.
The results presented in this publication document that
PathoQuest’s proprietary NGS approach is an effective and more
robust replacement to in vivo adventitious virus testing of cell
substrates used in the production of biologics, including
monoclonal antibodies, vaccines, cell and gene therapies.
What was the Study? The objective of the study was to
compare classical in vivo testing methods used to screen cell lines
for adventitious viruses with a GMP-compliant viral transcriptome
NGS assay. The study was conducted as a head-to-head comparison of
standard in vivo testing and NGS-based testing of cell substrates.
Charles River’s leading Biologics experts prepared the test
materials and ran the in vivo assays, while PathoQuest’s team
tested the material using their proprietary NGS-based assay.
Cells were infected with a wide variety of viruses which are
reflective of the diversity and various patterns of virus-cell
interactions in a real world setting for biologics to determine the
range of detection. The infected cells were increasingly mixed with
uninfected cells to assess the analytical sensitivity and analyzed
across several conventional in vivo tests and with the NGS-based
transcriptomic assay. Non-infected cell lines were used as controls
for the study. The PathoQuest transcriptomic assay demonstrated a
higher capability to detect cell infection including infection by
viruses not detectable with standard in vivo tests.
What are the Implications of the Study? The International
Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) has released a draft version of
ICH Q5A(R2) which provides proposed updated guidelines on the
testing and evaluation of the viral safety of biotechnology
products derived from cell lines of human or animal origin.
This update is a result of advances in scientific knowledge and
biotechnologies since the release of the original ICH Q5A(R1)
guideline in 1999. Examples of advances include the development of
new types of products like genetically engineered viral vectors,
and the availability of new and more robust viral safety
technologies, like NGS.
Another important aspect of the proposed revised guidelines is
their support for the use of new testing methodologies that align
with the 3Rs (the Replacement, Reduction and Refinement of animals
used in research). The results of the present study support the use
of the evaluated NGS-based transcriptomic assay as a superior
alternative to current in vivo testing methods and aligns with the
proposed ICH Q5A(R2) guidelines which are anticipated to be
finalized and implemented by the end of 2023. The data are suitable
to justify in vivo assay replacement by using the “Prior Knowledge”
principles also outlined in the ICH Q5A(R2) draft.
This project was funded by Charles River and PathoQuest,
understanding the importance of the results for future viral safety
testing strategies.
Approved Quotes
- “The use of NGS addresses the limitations of current testing
approaches for viral contaminants and enables clients to follow the
3Rs principles of replacement, reduction, and refinement of
animal-use methods. Additionally, unlike current general virus
screening testing methods, the agnostic transcriptomic NGS approach
combines both the detection and identification of known and unknown
viruses and has the capacity to replace additional virus testing
methods, like the cell based in vitro assays or even single PCR
assays.” –Horst Ruppach, PhD, Executive Director Scientific and
Portfolio for Global Biologics at Charles River
- “Our study demonstrates that PathoQuest’s unique NGS assay
significantly increases the capability of detecting viral
contaminations in cell substrates like cell banks, the starting
material for biologics production, and in bioreactors during
biologics production. The test has been validated to GMP standards
and provides the pharmaceutical industry a faster, more efficient,
and reliable testing option compared to animal-based testing.” –
Professor Marc Eloit, DVM, PhD, Head of the Pathogen Discovery
Laboratory at the Institut Pasteur and Founder of PathoQuest
About Charles River Charles River provides essential
products and services to help pharmaceutical and biotechnology
companies, government agencies and leading academic institutions
around the globe accelerate their research and drug development
efforts. Our dedicated employees are focused on providing clients
with exactly what they need to improve and expedite the discovery,
early-stage development and safe manufacture of new therapies for
the patients who need them. To learn more about our unique
portfolio and breadth of services, visit www.criver.com.
About PathoQuest With over 20 peer reviewed publications
on NGS applications, PathoQuest is a leading expert in the
application of Good Manufacturing Practices (GMP)-compliant Next
Generation Sequencing (NGS)-based biosafety testing. PathoQuest
offers biopharmaceutical companies a game-changing genomic approach
to ensuring the safety of biologics such as cell and gene therapy
products, vaccines, and recombinant proteins, ultimately enabling a
reduction in the time to market for these innovative treatments.
PathoQuest’s technology combines NGS platforms with proprietary
sample preparation and data analysis processes to bring novel
solutions to the industry. PathoQuest, headquartered in Paris,
France, with a US based site in Wayne (PA) has worked with over 100
of the leading biopharmaceutical companies globally. To learn more
about our service offerings and how we can help you to transition
to animal free testing, visit pathoquest.com.
To learn more about PathoQuest’s GMP validated transcriptomic
assay for adventitious virus detection and testing strategies to
enable the transition to animal free testing, visit
www.pathoquest.com/adventitious-virus-testing
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Charles River Investor Contact: Todd Spencer, Corporate
Vice President, Investor Relations +1-781-222-6455
todd.spencer@crl.com
Charles River Media Contact: Amy Cianciaruso Corporate
Vice President & Chief Communications Officer +1-781-222-6168
amy.cianciaruso@crl.com
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