Quality Control of Biologics

Regulatory &
Quality

Why PathoQuest?

The company has fully validated NGS-based testing methods, from sample preparation protocols to actionable reports, including bioIT analysis, based on ICHQ2R1 guidelines.

In November 2021, we have obtained a Good Manufacturing Practices (GMP) certificate for our quality control testing activities at our French-based facilities in Paris (France), following the inspection by the French National Agency for the Safety of Medicine and Health Products (ANSM).

The biomanufacturing industry is entering a new phase and regulatory authorities have recognized the potential of NGS with regulations now being revised to take advantage of this method. The final adoption of these new regulations is planned for 2021/2022 with a standardization working group having been established by the National Institute for Biological Standards and Control (NIBSC).

User driven. Data Informed.

Next-generation sequencing (NGS) is a fast and reliable quality control test for adventitious agent detection and viral stock characterization which can supplement and potentially replace sub-optimal traditional methods.

Our IT infrastructure and the associated data integrity and security are in compliance with 21 CFR part 11.
We are the 1st French laboratory with a GLP certificate grade A for NGS analysis following the successful inspection of our lab by ANSM in December 2019 (“high-throughput sequencing detection of incidental replicative virus test in eukaryote cells”)..
As per September 2020, our french site has obtained the administrative authorization of the Pharmaceutical Establishment from the French ANSM for its biological drug testing activities.

Download all of our certificates here.

As per September 2020, our french site has obtained the administrative authorization of the Pharmaceutical Establishment from the French ANSM for its biological drug testing activities.

Download all of our certificates here.

We are an active advocate for the decreased use of laboratory animal testing based on the 3Rs initiative. We provide the tool to not only replace animal testing but to also enhance QC testing
We are an active advocate for the decreased use of laboratory animal testing based on the 3Rs initiative. We provide the tool to not only replace animal testing but to also enhance QC testing

As a leader in providing NGS solutions, PathoQuest is part of this global initiative with our senior team being members of groups like Advanced Virus Detection Technologies Interest Group (AVDTIG) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

As a leader in providing NGS solutions, PathoQuest is part of this global initiative with our senior team being members of groups like Advanced Virus Detection Technologies Interest Group (AVDTIG) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

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Welcome to PathoQuest!

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