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Biosafety Open Forum

Industry Workshop on NGS-Based Biosafety Testing, co-hosted by Bristol-Myers Squibb (BMS)

Summary of Event on September 16th, 2021

After a successful Biosafety Open Forum in December 2020, Genedata and Bristol-Myers Squibb decided to continue the discussion with a follow-up event in 2021.  With 16 biopharmaceutical companies present, this industry workshop served to facilitate knowledge exchange around the use of NGS for adventitious agent detection and the challenges associated with assay design, optimization, and data analysis. Focus areas included biosafety testing during vaccine development and preparation for submission to regulatory authorities.

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Presentations

The participants received a warm welcome from Anurag Khetan,  Executive Director, Global Upstream and CLD, Biologics Development at Bristol Myers-Squibb who introduced the event by sharing the motivation of BMS for pursuing NGS-based viral detection. He highlighted the three main areas where adventitious agent detection is performed during the critical path timeline of First-In-Man studies in biologics development and manufacturing at BMS. Finally, Anurag explained the differences between conventional testing approaches and explained the promise of newer targeted and untargeted viral testing approaches.

Sanofi Pasteur’s Strategy for Implementing HTS for Adventitious Virus Detection

Siemon Ng, Head of Molecular Biology, Sanofi Pasteur

Siemon described how Sanofi Pasteur’s Analytical Sciences department has been applying High-throughput sequencing technology for the detection of adventitious viruses since 2011. High-throughput sequencing (HTS) is capable of detecting both known and unknown adventitious viruses that may be present in a sample. To demonstrate equivalency with existing tests, Sanofi Pasteur evaluated the detection sensitivity of HTS using a well-characterized panel of model viruses and determined the limit of detection within a viral seed matrix, and validated the assay within a GMP environment.

NGS-based Virus Safety Testing of Veterinary Master Seeds - Validation Data

Blandine de Saint Vis, Analytical Support Director, Boehringer Ingelheim Animal Health

Thanks to Blandine de Saint Vis, we gained insight into the viral purity testing approaches undertaken at Boehringer Ingelheim Animal Health (BIAH), striving to produce vaccines for animals including livestock and pets. A thorough analysis for viral contaminations in seed and starting material is crucial. Blandine shared an overview of the adventitious agent detection process and the objectives behind the BIAH’s motivation to embrace new approaches such as NGS. While sharing the benefits of NGS such as its speed, cost-effectiveness, and ability to detect all potential contaminants, Blandine also explained the complexities associated with the data analysis, validation, and determining criteria to define a true contaminant. To conclude, Blandine explained how BIAH validates NGS-based assays using a spike-in study and a panel of model viruses. She described the need to assess the reference database used and optimize the bioinformatics pipeline. Her team is currently using Genedata Selector’s bioinformatics pipeline for NGS-based data analysis. 

 

Demo: NGS for Adventitious Agent Detection: Analysis Options and Consequences

Devon Ryan, Scientific Consultant, Genedata

This presentation expanded the understanding of the analysis requirements of successful adventitious agent detection. Starting with the structure of a basic pipeline, Devon shared other approaches to improve the sensitivity and specificity of an NGS-based biosafety assay. He also discussed the impact of the selected reference viral database (RefSeq or C-RVDB) on the results obtained. Further studies performed by the scientific consultant team of Genedata identified the likely sources of false positives demonstrating the need to sequence the host cell line genome. Devon concluded by explaining how Genedata Selector simplifies the data processing and analysis of NGS-based biosafety assay data while allowing rapid data query for efficient decision-making. The automation and easy reporting capabilities of the software also enable companies to obtain the documentation they need for regulatory compliance.

Open Discussion

The open forum ended with an interesting discussion where participants asked questions regarding the adoption of NGS-based biosafety testing, as well as the challenging aspects of using this approach. The panelists provided key insights and advice to companies considering NGS-based biosafety testing. Emphasis was on optimizing the bioinformatics analysis, ensuring the quality of databases used, and collaborating with regulatory authorities.  

Agenda

EDT

CEST

THURSDAY, SEPTEMBER 16th, 2021

9:00 am3:00 pmWelcome and Introduction to the Participants
Anurag Khetan, Executive Director, Global Upstream and CLD, Biologics Development at BMS
Thomas Hartsch, 
Head of Selector Business, Genedata
9:10 am3:10 pmSanofi Pasteur’s Strategy for Implementing HTS for Adventitious Virus Detection
Siemon Ng, Head of the Molecular Biology Centre at Sanofi Pasteur Analytical Science, Sanofi Pasteur
9:35 am3:35 pmDemo: NGS for Adventitious Agent Detection: Analysis Options and Consequences
Devon Ryan, Scientific Consultant, Genedata
9:55 am3:55 pmNGS-based Virus Safety Testing of Veterinary Master Seeds - Validation Data
Blandine de Saint-Vis, Global MSAT Bio-Analytics, Senior Scientist, Boehringer Ingelheim Animal Health
10:20 am4:20 pmPanel Discussion on Wet Lab, Bioinformatics and Regulatory Challenges
Siemon Ng, Head of the Molecular Biology Centre at Sanofi Pasteur Analytical Science, Sanofi Pasteur
Blandine de Saint-Vis, Global MSAT Bio-Analytics, Senior Scientist, Boehringer Ingelheim Animal Health
Veera Dheenadhayalan,
Director Biosafety at AstraZeneca

Moderated by Thomas Hartsch, Genedata
11:00 am5:00 pmEnd of Event

Disclaimer

“The purpose of our gathering and discussions is to start a pre-competitive R&D collaboration and discuss best practices using NGS-based 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.”