Quality & Regulatory

CUSTOMER CHALLENGE

Finding a suitable expert partner to assist with your GMP biosafety testing and characterization needs is critical as these tests often form the bottleneck for release of product to patients.

With the iDTECT^® platform of Quality Control (QC) assays, we provide cGMP and fully validated NGS-based testing methods, from sample preparation and bioinformatics analysis to actionable reports, according to the ICHQ5A(R2), ICHQ5B, ICH Q2(R2) and Q14 international guidelines.

PathoQuest is the trusted Quality Control (QC) supplier for many biotech/pharmaceutical companies navigating IND/IMPD projects and BLA/MAA authorizations.

OUR MISSION FOR QUALITY

At PathoQuest, we are committed to maintaining the highest standards of quality and compliance. Whether it’s ensuring the safety of the biologics products of our clients or adhering to regulatory requirements and/or guidelines, we take every step to meet and exceed industry requirements:

Replacement of animal-based models according to the 3Rs recommendation

GMP and validated methods

Global operations with 2 mirror GMP sites in EU and US with common methods, tools, digital infrastructure, and Quality System: Paris (France) and Wayne (PA)

Bioinformatics and IT infrastructure in compliance with 21 CFR part 11 and Annex 11

Submissions to Regulatory Agencies (FDA, EMA)

Our robust quality system, regulatory compliance, and adherence to GMP standards enable a straightforward adoption of our assays.

“

“ The mission of PathoQuest is to ensure compliance and safety. We strive to de-risk the product development pipeline by preventing adventitious agent contamination and misidentification of cell lines.

Our NGS assays, available in both non-regulated and regulated environments, empower us to deliver high-quality results to our global customers.”

Sébastien Renouf (PharmD) | Chief Pharmaceutical Officer & Qualified Person | Pathoquest

Quality Assurance (QA)

Quality System: We have a robust digital DMS and QMS in place, encompassing every aspect of our operations from the laboratory to final reports/certificates.
GMP Certificates:

Human Investigational Medicinal Products

Human Medicinal Products

Manufacturing and Import Authorization (MIA): Our sites are registered with the French Medicines Agency (ANSM).

Certificate of MIA (FR)

FDA Sites Registration: learn more

Virology Expertise: Our scientific experts ensure that our testing services are virologically meaningful, reliable, and safe. For agnostic assay, the study report is systematically supported by a virology expertise report.

Regulatory Affairs

ICH Guidelines Reference: Our tests are in accordance with the International Council for Harmonization (ICH) guidelines, especially those related to viral and genetic characterization (ICHQ5A and ICHQ5B)

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New ICHQ5A(R2) Highlights the Benefits of NGS : Learn More »

3.2.3: “NGS is encouraged as a replacement for in vivo assays because it can overcome the limitations of the breadth and sensitivity of virus detection of the in vivo assays. Furthermore this promotes the global objective to replace, reduce, and refine the use of animal testing.”

The guideline also refers to NGS as a replacement for:

– Mouse, Rat and Hamster Antibody Tests (3.2.4)
– Retrovirus assays (3.2.1)
– In vitro adventitious virus tests (3.2.5)

FDA BMF Numbers: Our assays have unique Biological Master File (BMF) numbers issued by the FDA.

ANSM & EMA: We actively participate in regulatory discussions with Agence Nationale de Santé et de Sécurité du Médicament (ANSM) and European Medicines Agency (EMA).

- - - ANSM minutes: Substitution of in vitro and in vivo virus testing with PathoQuest Transcriptome assay. Learn more
    - Innovation Task Force Briefing Summary held with the EMA (2024 03 24): Substitution of in vitro and in vivo Virus Testing by iDTECT^® Transcriptome assay. Learn more

The views expressed in this document are the opinion of the participating members of the Innovation Task Force and the experts, and may not reflect the opinion of the EMA scientific committees

- - - EMA Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products. Learn more

Pharmacopea 2 6 16: Our vaccine-related tests align with the relevant pharmacopoeial standards.
Collaboration with the European Directorate for the Quality of Medicines & HealthCare (EDQM) on cutting-edge research: Meeting hold in DEC 2023 with the members of the EDQM Gene Therapy Working Group. The Group consists of the 11 OMCLs (Official Medicines Control Laboratories) and the members are mostly regulators from Europe, one from Canada and an observer from Asia: Learn more

WHO Adoption: We follow World Health Organization (WHO) recommendations for vaccine development.
Genetic Characterization (US Guidelines): : Our expertise extends to genetic characterization, in line with U.S. guidelines.

Ready to elevate your quality standards?

Contact us

U.S.

+1 484 212 9360

466 Devon Park Dr
Wayne, PA 19087
United States

E: contact@pathoquest.com

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France

+33 (0)1 70 82 17 90

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

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