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Diving Deeper into GMP-Ready NGS: Contamination Control & Genetic Characterization 

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This seminar brings together industry experts to explore the transformative role of Next Generation Sequencing (NGS) in biopharmaceutical quality control and genetic characterization. The session opens with a focused discussion on advancing contamination control through GMP ready NGS workflows, highlighting how regulatory shifts—including ICH Q5A(R2)—are driving the adoption of NGS for viral safety and microbial detection in manufacturing environments.

 

Building on this foundation, the seminar delves into the optimization of genetic characterization using NGS, covering applications from cell line authentication to vector integrity and genetic stability assessment. Attendees will gain practical insights into implementing NGS across the product lifecycle, from early development to QC release, while navigating the evolving regulatory landscape and validation expectations.

 

This NGS seminar is delivered in collaboration with Life Sciences Queensland (LSQ).

 

Why Attend?

  • Stay ahead of regulatory changes: Understand how ICH Q5A(R2), FDA, and global guidance are shaping NGS adoption in GMP environments.
  • Enhance contamination control: Learn practical strategies for integrating NGS into viral safety and microbial detection workflows.
  • Optimize genetic characterization: Discover how NGS enables deeper, more comprehensive cell line and gene therapy product profiling.
  • Navigate validation and implementation: Gain real world perspectives on bringing NGS into regulated QC laboratories.
  • Drive digital transformation: Explore how NGS data integration and bioinformatics can improve decision making and operational efficiency.

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