White Papers

  1. 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.

  2. Building A Scalable Digital Foundation To Support CGT Manufacturing 1/29/2026

    Explore how digital systems strengthen CGT manufacturing by improving traceability and managing batch‑of‑one, as well as essential steps toward scalable, integrated operations.

  3. Selecting A CDMO For Custom Activated PEGs 1/27/2026

    Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.

  4. Open-Label Study Assessing Relative And Absolute Bioavailability 1/26/2026

    Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

  5. Unlocking The Potential Of Biocatalysis 1/22/2026

    Biocatalysis delivers cleaner, more selective pharma processes while cutting energy use and waste. Engineered enzymes broaden their reach, enabling faster development and greater sustainability.

  6. Leveraging Flow Chemistry 1/22/2026

    Discover how continuous processing cuts waste, improves efficiency, and supports safer, scalable reactions while helping teams meet sustainability goals and speed development.

  7. Building The Business Case For LIMS 1/21/2026

    Explore how digital workflows and automation deliver measurable ROI and competitive advantage for life sciences organizations navigating complex manufacturing challenges.

  8. Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC 1/21/2026

    Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.

  9. Smart Manufacturing: A Strategic Imperative For Pharma's Future 1/15/2026

    Pharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.

  10. Why Choose Robotic Processing For Small Batch Aseptic Filling 1/9/2026

    Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.