Cell and Gene Regulatory

  1. Transforming Development Through Mass Spectrometry Data Analysis 1/29/2026

    Mass spectrometry is vital for understanding PTMs in modern biologics. Explore key challenges and how streamlined analysis can reveal deeper, more sensitive insights into biotherapeutic structure.

  2. ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials 1/29/2026

    Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

  3. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

    International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

  4. NGS-Based Assays In CGT: Enhancing Product Development 1/29/2026

    Examine how NGS brings essential clarity to cell and gene therapy development by enabling sensitive biosafety testing, detailed genetic characterization, and reliable stability monitoring.

  5. NGS In GMP Manufacturing: Reducing Risk, Increasing Return 1/29/2026

    Global regulators now recognize NGS as a rigorous, GMP‑ready tool for viral safety, driving a shift toward scalable quality strategies. Learn why NGS is becoming central to modern manufacturing.

  6. Enabling NGS-Based Product Characterization And Biosafety Assays 1/29/2026

    Evolving regulations are shaping the adoption of NGS for biosafety and product characterization. Learn what teams must consider when validating modern sequencing assays within GMP‑regulated environments.

  7. A Cloud-Based Computational Protocol To Detect Adventitious Viruses 1/29/2026

    Advanced NGS bioinformatics pipelines and curated viral databases enhance the detection of adventitious agents. Learn how cloud-based protocols ensure rigorous safety assessments and maintain compliance.

  8. Advanced NGS Techniques For Cell Line Characterization In CGT 1/29/2026

    Discover how in‑house NGS and robust data management streamline CQA analysis, reduce risk, and strengthen development workflows from early research through manufacturing.

  9. Genetic Stability Testing Using NGS And MAM 1/29/2026

    New sequencing and analytical strategies offer deeper insight and greater confidence in long-term cell line performance. Explore how modern tools improve accuracy while simplifying development workflows.

  10. Next-Gen Cell Line Characterization For Safer, Faster Drug Development 1/29/2026

    Modern development depends on thoroughly characterized cell lines. See how next‑generation sequencing strengthens identity, purity, and stability assessments while supporting global regulatory standards.