Cell Therapies
CUSTOMER CHALLENGE
Cell therapies come in many different forms, for many different applications, including gene-modified therapies such as CAR-T, as well as unmodified stem cell therapies. Cell therapies can also be classed as allogeneic or autologous. This means that every individual therapy requires a highly individualized approach to characterization and testing.
Traditional testing approaches are often not suited to cellular inputs. Indeed, testing in this way requires large volumes which developers can struggle to supply. Customers must therefore find alternative testing and release strategies for these life-changing cell therapies. PathoQuest supports these needs by providing advanced cell line testing, iPSC characterization, and stem cell characterization to ensure the highest quality and safety standards are met.
PATHOQUEST SOLUTION
PathoQuest can help characterize, QC and release your cell therapies across the manufacturing journey
DISCOVERY
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
MARKET
Cell selection/characterization of modifications on/off target
Cell line characterization – MCB, WCB, End of Production
In-process testing – bulk harvest lot release, biosafety and viral testing
Final product release testing – identity testing
Raw material screening
Investigatory support
PATHOQUEST SOLUTION
PathoQuest can help characterize, QC and release your cell therapies across the manufacturing journey
OUR EXPERTISE
PathoQuest has successfully developed and delivered GMP characterization and release tests for many cell therapy applications. By using our expert NGS services, clients have been able to overcome volume and compatibility issues with traditional animal or cell-based testing and characterization assays, allowing them to deliver their life-changing cell therapy to patients. Our services include Cell Therapy quality control, iPSC characterization, stem cell characterization, and CAR-T Release Testing, ensuring that every therapy meets the highest standards of safety and efficacy.
PathoQuest actively participates in regulatory and expert industry interest groups, associations, and consortia, as well as frequently publishing in peer-reviewed journals. We lead the way in both innovation and acceptance of NGS technology, especially when applied to the specific challenges of viral vector QC.
CHALLENGES SOLVED
PathoQuest addresses the key challenges you face in manufacturing and releasing your cell therapy by addressing key concerns:
- Faster development and candidate selection with deeper genetic insights, especially for on- and off-target modifications
- De-risking your approach by rapidly screening critical raw materials such as donor material and plasmids
- Reducing the characterization bottleneck, including iPSC characterization and stem cell characterization, allowing you to get your therapy into clinic faster
- Ability to use less of your precious cell product with much smaller volume demand
- Providing additional assurance of biosafety where traditional testing strategies are not possible
- Meeting corporate 3Rs ethical objectives by removing animal models
- Enhancing Cell Therapy quality control to ensure the highest standards for therapeutic products
Modalities
mAbs and Recombinants
Bacterial and mammalian produced proteins, hormones and peptides
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Viral Vectors
Viral gene delivery, oncolytic and immunotherapy including manufacturing plasmids
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Cell Therapies
Including gene modified, or unmodified stem cell therapies, allogeneic or autologous
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Vaccines
Inactivated, live-attenuated, recombinant, RNA and viral vector products
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RNA
Immunotherapies, antiviral, vaccines, RNAi and CRISPR based gene editing
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Cultivated Meat
Engineered cells and tissues cultured in more ethical in vitro environments
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Contact us
France
+33 (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
How can PathoQuest help?
U.S.
466 Devon Park Dr
Wayne, PA 19087
United States
France
+33 (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
How can PathoQuest help?
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