White Papers

  1. Pave The Way To High Productivity With Continuous Manufacturing For Pharma 12/12/2025

    Continuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.

  2. FDA's Regenerative Medicine Advanced Therapy (RMAT) Program 12/10/2025

    RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

  3. Challenges And Solutions In Lyophilization Development For ADCs 12/10/2025

    Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

  4. Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter 11/10/2025

    Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.

  5. Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow 11/7/2025

    Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.

  6. Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow 11/7/2025

    Discover a high-efficiency workflow for generating GFP-expressing CHO-K1 clones using automated single-cell dispensing to achieve 93% isolation success and stable expression in under five weeks.

  7. Sustainability In Small Molecule API Manufacturing 11/7/2025

    Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.

  8. Build An AAV8 Platform: Lessons From A Collaborative Development Journey 11/5/2025

    Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

  9. Excellence In Peptide And Oligonucleotide Purification 11/5/2025

    Explore how digital tools are advancing peptide purification, with a focus on GLP-1 receptor agonists, as well as how process efficiency can be accelerated through real-time insights.

  10. Tools For Efficient And Reliable Gene Therapy Manufacturing 11/5/2025

    Discover scalable strategies for overcoming AAV purification challenges, from low yield and impurity removal to serotype variability, as well as how advanced tools can streamline manufacturing.