Regulatory

Regulatory acceptance

Our iDTECT® NGS-based assays meet the highest regulatory requirements in biotesting, guaranteeing accuracy, reliability and compliance.

GMP

GMP

Compliant with ICH Q5A & Q5B

Biologics Master Files (FDA)

Regulatory guidance for viral safety

  • Supporting NGS as an alternative to traditional in vivo assays in line with ICHQ5A(R2) and Ph. Eur.

Our iDTECT® NGS assays are validated in accordance with key regulatory guidelines, including ICH Q5A(R2) and the European Pharmacopoeia. These guidelines recognize the advantages of NGS over traditional in vivo assays, emphasizing its superior sensitivity and broad range of detection capabilities.

ICH Q5A(R2) 3.2.3: NGS is encouraged as a replacement for in vivo assays due to its enhanced detection capabilities and alignment with global objectives to reduce animal testing.

Ph. Eur. 5.2.14: Highlights the ability of NGS to detect previously undetected viral contaminants, thereby identifying gaps in existing testing strategies.

Ph. Eur. 2.6.16 and Ph. Eur. 5.2.3 support the use of NGS as an alternative to in vivo and specific NAT or as supplement or alternative to in vitro culture tests for extraneous agents testing in vaccine production.

  • Replacing traditional biotesting methods with NGS for:

In vivo testing. Download our publication in Vaccine.

Mouse, Rat, and Hamster Antibody Production Tests: ICH Q5A(R2) 3.2.4. Download our application note.

In vitro adventitious virus tests and cell culture infectivity assays: ICH Q5A(R2) 3.2.2.

Molecular methods: ICH Q5A(R2) 3.2.5.

Ph. Eur. 2.6.41. (draft, April 2024) provides with comprehensive guidance on NGS methodologies for viral extraneous agents detection in biological products, including method design, workflow steps, analysis approaches, routine controls, and validation procedures, with the aim of facilitating the implementation of NGS-based adventitious virus testing.

Regulatory guidance for genetic characterization

  • Complying with ICH Q5B and Ph. Eur. 5.14

ICH Q5B III.A. Expression Construct and Cell Clone: DNA sequencing is required to determine the nucleotide sequence of the coding region of the gene of interest, including associated flanking regions inserted into the vector, and the junctions of insertion.

ICH Q5B III.B. Cell Bank System: Allows the use of alternative suitable techniques for the analysis of the expression construct for integration sites and configuration of expression constructs.

Ph.Eur. 5.14 and ICHQ5B emphasize the need for precise genetic characterization, including the identity of the transgene, regulatory elements and detection of variations greater than 5%.

Proactive engagement with regulatory bodies and expert groups

  • Registered Biologics Master File at the FDA (Food and Drug Administration) for iDTECT® assays
  • Consultations with regulatory authorities:

ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé):

ANSM minutes: Substitution of in vitro and in vivo virus testing with PathoQuest Transcriptome assay. Download the report.

EMA (European Medicines Agency):

Substitution of in vitro and in vivo virus testing by iDTECT® Transcriptome assay (2024 03 24): Download the report.

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.

  • Participation in regulatory committees such as the European Directorate for the Quality of Medicines & HealthCare (EDQM) on cutting-edge research:

Meeting held in December 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. See the agenda.

  • Membership in expert groups:

EFPIA (European Federation of Pharmaceutical Industries and Associations) since 2019.

Position paper on Next Generation Sequencing (NGS) for adventitious virus detection in biological medicinal products, with key contributions from PathoQuest. Download the position paper.

AVDTIG (Advanced Virus Detection Technologies Interest Group) since 2014.

Quality

Quality is at the core of our operations. Our digital Quality Management System (QMS) and Document Management System (DMS) ensure excellence in laboratory procedures, reports and certificates.

Ready to elevate your quality standards?

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?

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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

How can PathoQuest help?

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

Sign up for our latest news