Quality Control of Biologics

NGS THE NEW ALTERNATIVE TO IN VIVO TESTING

Is your Viral Safety Program 3Rs Compliant?

Based on UMI market test about the use of NGS to replace animal tests for the viral safety of biologics performed between Dec.20 and Feb.21 on a panel of the biopharma stakeholders:

In collaboration with Charles River Laboratories (CRL), we are now the first contract research organization (CRO) to conclusively show the superiority of NGS over conventional in vivo biosafety testing methods for 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.

NGS adoption becomes a must in anticipation of the upcoming ICHQ5A revision

This study will show you detailed criteria of the benefits of switching from animal testing to NGS for the viral safety of your biologics.

At PathoQuest, we are active advocates for the decreased use of laboratory animal testing based on the 3Rs initiative. We provide the tool to not only replace animal testing but also enhance QC testing

At PathoQuest, we are active advocates 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

Regulations are changing

This is most evident in the European guidelines where there has been a concerted effort to update several documents, including ICH Q5A, last assessed in 2019 (13), to include NGS as an alternative to traditional animal- (in vivo) and cell-based (in vitro) testing for the detection of adventitious viruses. More recently, in September 2021, the European Medicines Agency (EMA) published new measures to limit animal testing in the context of drug development. In this context, NGS-based testing stands as an ethical alternative to in vivo testing.

The international ICH Q5A regulations updated draft version should be released by the end of 2022.

Three Rs principle

Developed in 1959, the 3-Rs are the ethical approach applied to animal experimentation in Europe and North America which recommends reducing number of animals in experiments, refining 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 “three Rs” principle on animal experimentation, the regulatory bodies are indeed pushing to limit the use of animal models only when there are no other alternatives.

WHAT ARE THE BIOLOGICAL MATERIALS CONCERNED BY A SWITCH?

Vaccines, Recombinant proteins, cell & gene therapies…

 

WHAT SEQUENCING METHOD HAS BEEN USED FOR THE COMPARATIVE STUDY?

NGS transcriptomic approach on cells

WHAT TESTS CAN BE REPLACED?

In vivo = Suckling mice, adult mice, embryonated eggs, guinea pigs

WHAT SEQUENCING METHOD HAS BEEN USED FOR THIS STUDY?

NGS transcriptomic approach

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