3Rs

NGS VS ANIMAL TESTING

The 3Rs model (Replacement, Reduction and Refinement) to ensure the ethical treatment of animals has seen a significant move away from both direct and indirect animal testing models. An alternative testing strategy is long overdue with a legacy of no known in vivo testing positives despite a history of known contamination events in biologics.

In collaboration with Charles River Laboratories (CRL), PathoQuest is the first contract research organization (CRO) to conclusively show the superiority of next-generation sequencing (NGS) over conventional in vivo biosafety testing methods on cells. The ability of our RNA sequencing based strategy to detect more broadly and deeply biological contaminants in biologics than in vivo testing is clear.

Replacement

Reduction

Refinement

3Rs PRINCIPLE

Developed in 1959, the 3Rs is the ethical approach applied to animal experimentation in Europe and North America which recommends reducing the number of animals in experiments, refining the methodology used, and replacing animal models.

A major advantage of NGS has been highlighted by recent regulatory changes driving the reduction in the use of animals for viral safety tests. To comply with the ‘3Rs’ principle on animal experimentation, the regulatory bodies are indeed pushing to limit the use of animal models only when there are no other alternatives.

REGULATIONS ARE CHANGING

The biomanufacturing industry has entered a new phase and regulatory authorities have recognized the potential of NGS with new regulations adopted in November 2023.

The International Conference on Harmonisation (ICH) has published a new guideline Q5A(R2) for the viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.

This revision 2 (R2) highlights the benefits of Next Generation Sequencing assays versus in vivo assays.

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).

BENEFITS OF NGS VS ANIMAL TESTING

NGS combines the advantages of classical in vivo testing methods while overcoming many of the drawbacks and challenges associated with in vivo including specificity, sensitivity, and speed.

Download PathoQuest’s in vivo brochure for more information on the specific benefits of NGS vs animal testing.

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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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

E: contact@pathoquest.com

How can PathoQuest help?

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

Sign up for our latest news