Outsourced Pharma App Notes & Case Studies

  1. Understanding The EU Regulatory Landscape For Cell And Gene Therapies 4/9/2026

    EU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.

  2. Redefining Cell Line Development For Next-Generation Biologics 4/30/2026

    A transposon‑enabled cell line development strategy streamlines upstream optimization, shortening timelines while improving consistency, yield, and quality across recombinant protein modalities.

  3. Set Up And Qualify GMP Laboratories 7/10/2025

    See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

  4. Accelerated LVV Manufacturing Enabled By Platform Excellence 11/25/2025

    Discover how a manufacturing platform enabled the rapid production of lentiviral vector in eight months. Learn the strategy used to balance speed, risk mitigation, and the highest quality standards.

  5. Shear and Flow In High-Productivity Membrane Affinity Chromatography 3/25/2025

    Can high flow rates and turbulent conditions compromise protein quality? This analysis explores the relationship between fluid dynamics and aggregation in membrane and resin chromatography systems.

  6. Accelerate LNP Manufacturing With Automated Process Development 2/5/2026

    Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.

  7. Case Study: ThioBridge™ Conjugates 4/14/2025

    Discover how Abzena’s ThioBridge™ technology is enabling the next generation of stable, scalable, and clinically advanced ADCs through site-specific conjugation.

  8. Producing Quality APIs At Scale 5/7/2026

    Targeted process optimization transformed an early‑phase API with yield and impurity challenges into a scalable, high‑quality manufacturing process ready to support ongoing drug development.

  9. Optimized Transient Transfection Platform: AAV Program From Gene To GMP 12/2/2025

    Achieve faster AAV gene therapy progress by adopting a unified platform for manufacturing. Accelerate your program to GMP readiness with up to 9x higher titers and robust, high-quality full capsid yields.

  10. 3D Screen Printing: Enabling A New Generation Of Complex Formulations 3/17/2025

    Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.