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 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.

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
  • Reducing the characterization bottleneck, allowing you to get your therapy into clinic faster
  • Ability to use less of your precious cell product reducing 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

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

U.S.

+1 484 212 9360

466 Devon Park Dr
Wayne, PA 19087
United States

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France

+33 (0)1 70 82 17 90

Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France

How can PathoQuest help?

Name(Required)
This field is for validation purposes and should be left unchanged.

U.S.

+1 484 212 9360

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?

Name(Required)
This field is for validation purposes and should be left unchanged.

Sign up for our latest news