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Biosafety

Biosafety Open Forum

Industry Workshop on the Present and Future 
of NGS-Based Biosafety Testing, co-hosted by BMS

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First Virtual Industry Workshop on NGS-Based Biosafety Testing

In collaboration with Bristol-Myers Squibb, Genedata Selector organized and co-hosted an industry workshop on December 10th, 2020.

This interactive event brought together key experts from 9 companies to facilitate knowledge sharing and industry discussions related to key challenges and opportunities in the field of biosafety testing. Featured themes included NGS-based adventitious virus detection, its impact in accelerating clinical timelines, and the benefits and challenges related to implementation in biopharma companies.

This event was an opportunity for the biopharma industry to raise questions to experts in the field while sharing and exchanging ideas regarding best practices using NGS-based biosafety as well as the need to identify adventitious agents during biopharma R&D.

Presentations

Rapid Methods for Adventitious Virus Detection - Acceleration of Clinical Timelines - Speed to Patient

Jürgen Müllberg, Principal Scientist Viral Safety SME, BMS

Contamination of a biological product with viruses, potentially harmful for humans, is of concern for therapeutics derived from human and animal sources, i.e. plasma, and for protein therapeutics and vaccines produced in mammalian cells.  More recent “Advanced Therapeutic Medicinal Products (ATMPs)”, such as gene and cell therapies, share the same concern.  Tests for viral contaminants are performed at several stages of manufacturing.  Current tests for detection of viruses are lengthy; cell culture based assays and animal experiments are required.  Alternative molecular tests, such as “next generation sequencing (NGS)”, provide faster results, and can eventually replace in vivo animal studies.  It is noteworthy that identification of a viral contaminant that evaded detection in classical tests, by NGS, has been demonstrated.  Since NGS based virus tests yield results significantly faster than current assays, additional applications for in-process testing and viral contamination control can be envisioned.  In this presentation applications for unbiased and targeted NGS in testing of biologics will be discussed.

Integration of NGS Biosafety Methods in Biopharma Companies - Benefits & Current Limitations

Fabio La Neve, Head of Analytical Development, Ibex at Lonza

Over the past few decades, technological advancements in NGS have enabled biopharmaceutical companies to adopt NGS for biosafety testing. During a typical manufacturing process, NGS-based biosafety is implemented at several stages to accelerate production and prevent large-scale contamination. Although some pharmaceutical companies benefit from faster results and reduced costs, widespread implementation of this technique has been slow due to challenges and complexities related to sample preparation, data analysis, bioinformatics, and evolving instruments. To overcome these limitations, we need to bring about harmonization by introducing standards to the terms, methods, and technologies used in this process. Now is the time to facilitate conversation between key players in healthcare to harmonize and improve the use of NGS-based biosafety in the pharmaceutical industry.

Horses for Courses: Thoroughbred Bioinformatics Pipelines for Virologists

Sebastien Ribrioux, Head of Scientific Consulting Genedata

As the efforts to harness NGS for adventitious agent detection gather pace, a greater understanding is emerging of how this technology can best be applied in different situations. Experimental protocols and bioinformatics pipelines are, for example, tailored to the type of therapeutic agent being produced, or the stage of production at which testing is taking place. Computational biologists face many choices when crafting NGS read processing and analysis pipelines, and may create several pipelines depending on different needs. Ideally, this expertise and knowledge should be encapsulated in a way that virologists can run the pipeline easily themselves, with results presented clearly so they can bring their expertise to bear. Where appropriate, the process should be automated to the extent possible: this is the next hurdle.

 

Demonstration of Viral Safety Data Analysis Workflow - Unbiased Approach

Namrata Sarkar, Scientific Account Manager, Genedata

Demonstration of how Genedata Selector can help you establish a standardized NGS-based method for virus testing and reporting.

Agenda of Industry Workshop on December 10th, 2020

EST

CET

Topic

Speaker

9:0015:00Welcome and Introduction to the ParticipantsAnurag Khetan, Senior Director Biologics Development, Bristol-Myers Squibb &  Thomas Hartsch, Head of Genedata Selector
9:1515:15Rapid Methods for Adventitious Virus Detection:  Acceleration of Clinical Timelines - Speed to PatientJürgen Müllberg, Principal Scientist / Viral Safety SME, Bristol-Myers Squibb
9.4515:45

Integration of NGS Biosafety Methods in Biopharma Companies: Benefits and Current Limitations

Fabio La Neve, Head of Analytical Development, Ibex at Lonza
10:0516:05Horses for Courses:  Thoroughbred Bioinformatics Pipelines for VirologistsSebastien Ribrioux, Head of Scientific Consulting, Genedata
10:2516:25BREAK 
10:4016:40OPEN DISCUSSIONAll Participants, moderated by Genedata
11:5017:50Demonstration of Viral Safety Data Analysis WorkflowNamrata Sarkar, Scientific Account Manager, Genedata

12:00 - 12:10

18:00 - 18:10

Final RemarksThomas Hartsch, Head of Genedata Selector

Disclaimer:  “The purpose of our gathering and discussions is to start a pre-competitive R&D collaboration and discuss best practices using NGS-bases biosafety to identify adventitious agents during biopharma R&D.  We consider our discussions to be pre-competitive in nature as the best practices can be used very broadly in the industry.  Please keep the conversation to this topic and refrain from bringing up topics that could be considered anti-competitive under antitrust/competition laws, such as pricing.”