Downloads

  1. Sterilizing-Grade Filtration Of mRNA Encapsulated Lipid-Nanoparticles 9/2/2026

    Compare sterilizing-grade membrane performance at high and low pressures, including throughput, bacterial retention, and the effects of filtration on particle diameter and encapsulation efficiency.

  2. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

    Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

  3. Role Of Membrane Chemistry And Filter Format In TFF 9/2/2026

    Compare hollow fiber and flat sheet TFF formats across three membrane chemistries, and see how filter selection can influence ambient-temperature UF/DF optimization, processing time, and quality.

  4. Enhancing mRNA-LNP Downstream Processing Via Single-Pass TFF 9/2/2026

    Single-pass tangential flow filtration effectively concentrates mRNA-LNPs and removes ethanol while maintaining quality. See how this approach produced LNPs with 4.2-fold higher in vitro potency.

  5. Risk Tool Selector: Match The Framework To The Decision 9/2/2026

    Match each CMC question to the right risk framework. See which tools help identify risk, reveal its drivers, and prioritize action across development and lifecycle risk management.

  6. Digital CMC Maturity: Rethinking QTTP And Control Strategy 9/2/2026

    Digital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.

  7. A QMS That Anticipates Cell And Gene Therapy Quality Challenges 9/2/2026

    Some quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.

  8. Using Digital Platforms To Find Your CDMO 9/2/2026

    In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.

  9. Understanding How Value by Design Can Bring Your Drug to Market Faster 9/1/2026

    See how predictive modeling and Quality by Design help reduce development costs, improve process understanding, and enable more confident decisions.

  10. Beyond Protein A: Efficient Purification Strategies For Misbehaving mAbs 9/1/2026

    Next-generation antibody formats require more precise purification strategies. Explore how subdomain-specific VHH ligands can address structural heterogeneity, improve purity, and preserve stability.