Next Generation Sequencing (NGS)

Pre-Conference Workshop on 25 June 2024

Objectives

This workshop will deal with the existing and announced relevant regulations in pharmacopoeias and guidelines and will present the collected comments of the ECA NGS Task Force on the planned Draft Ph.Eur. 2.6.41, which is to be published shortly. In addition, experts from industry, laboratories and service companies will report on their experiences with NGS.

Background

Next Generation Sequencing (NGS) has taken on an important role in drug control. This technology enables the rapid and precise analysis of DNA and RNA sequences. In terms of drug control, NGS can be used to verify the composition of drugs, including the identification of active ingredients, impurities or potential allergens.

NGS also enables the analysis of microorganisms in drugs, which is important to detect impurities that could affect the safety and efficacy of a drug. In addition, NGS can help identify genetic variants in patients that could influence the response to certain drugs, contributing to personalized medicine.

Overall, NGS enables a comprehensive analysis of drugs and can help to improve their quality, safety and efficacy.

Programme

Draft Ph.Eur. 2.6.41 – Content and Comments
Dr Sven M. Deutschmann, Roche
Dr Oleg Krut, PEI

  • Introduction
  • Comments from ECA “NGS”-Task Force


Revision (R2) of Guideline ICH Q5A on Viral Safety Evaluation of Biotechnology Products
Dr Astrid Schwantes, PEI

  • Updates in ICH Q5A(R2) with focus on the testing strategy and testing methods (including NGS)
  • NGS application to different biomedicinal products


Use of NGS to Identify Relationships in the Legal Context of Food Safety Controls
Coen van der Weijden, Netherlands Food and Consumer Product Safety Authority

  • NGS typing to identify relationships between food pathogen isolates.
  • The legal context of using NGS in official controls for food safety.
  • Connecting data from the human and food domain in the Netherlands and internationally.


GMP-Compliant Analysis of NGS Data for Detection of Contaminants, Identification of Bacterial and Fungal Strains, and Typing
Dr Stefan Emler, Smart Gene

  • Apps for easy processing of NGS datasets by non-bioinformaticians in routine laboratories
  • Meaningful, accurate and reproducible results also for QM/QC tests in biopharmaceutical production
  • AI-curated proprietary “Centroid” reference sequence databases with validated content and up-to-date nomenclature to support high-resolution identification of >16,000 bacterial species and >40,000 fungal species
  • User protocols and audit trails for full traceability of analyses


NGS Strategies from Sample to Report for Microbial Identification and Viral Contamination Detection in Pharma
Caroline Rosseel, Thermo Fisher Scientific

  • Ion Torrent NGS Technology Overview
  • The Advantage of NGS on Microbial ID and on Viral Safety Testing
  • Ion Torrent NGS Technology Approach for Microbial ID and for Viral Safety Testing
  • Analysis Solutions with Regulatory Compliance

 

Implementing Next Generation Sequencing technology under GMP
Snehit Mhatre, Eurofins

  • Scope of NGS in BioPharmaceutical market: Microbiome & Live Biotherapeutic Products
  • Difficulties in implementing NGS under GMP
  • Recommendations and guidelines


The way NGS is Shaping the Future of Food-Borne Outbreak Investigations in the Netherlands
Charlotte Verbart, Netherlands Food and Consumer Product Safety Authority

  • Collaboration between Public health and Competent Authority on food safety.
  • Traditional methods used in food-borne outbreak investigation, illustrated by the example of an outbreak of listeriosis.


Bacterial community structure and dominant species in pharmaceutical manufacturing water revealed by high-throughput sequencing
Saori Shikama, Takeda

  • Culture independent bacterial community structure analysis at cold WFI system
  • High-throughput sequencing that targets full length 16S rRNA gene effectively identified dominant species


Case Studies, Data and Experience on NGS
Doug Botkin, Charles River Laboratories

  • Current NGS applications for QC Micro
  • Future NGS applications for QC Micro
  • NGS challenges

Possibilities of NGS in virus safety in accordance to ICH Q5a R2
Anna Liznar, Pathoquest

  • Viral Safety of Cell Banks: Decluttering Animal-based Assays
  • Replacing Animal-based Tests with a single GMP NGS Test (iDTECT Transcriptome)
  • Ensuring Detectability: Assay Controls and Adoption to different Matrixes

 

Programme - Download

 

 

 
Programme of the Workshop as PDF.

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