Formulation Featured Articles

1. Risk Managing Through The Void Of ATMP Visible Particle Guidance 9/8/2026

   Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.

2. Looking Beyond Solubility And Process Performance 9/2/2026

   Solvent selection for spray-dried dispersions significantly impacts drug performance, scalability, and supply chains. Early, structured solvent choice is vital for successful manufacturing and commercialization.

3. Expanding Subcutaneous Design Brick By Brick 8/14/2026

   Biologics are growing more complex. But what if the syringe itself could unlock new possibilities? Discover the technology “bricks” quietly reshaping subcutaneous drug delivery.

4. Efficient Solutions Supporting Freezing And Storage Operations In Bulk Drug Manufacturing 8/13/2026

   Practical strategies for reducing handling steps, minimizing product loss risk, and improving operator efficiency in frozen drug substance cold chain operations.

5. Next-Generation Mesenchymal Stem Cells For Cancer And Regenerative Medicine 7/21/2026

   Researchers are advancing engineered mesenchymal stem cells using efficient non-viral gene delivery, enabling scalable, targeted therapies for solid tumors while preserving tumor-homing function and manufacturability.

6. Building A Self-Driving Lab For LNP Development 7/20/2026

   With commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.

7. Addressing The Particulate Challenge In Cell Therapy Products 7/15/2026

   Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.

8. Platform Strategy For Improving Manufacturability And Efficacy In Bispecific Antibodies 7/15/2026

   Novel bispecific antibody engineering overcomes assembly and manufacturability challenges, enabling scalable production while preserving therapeutic function, stability, purity, and product quality.

9. What's Hot In Freeze Drying? Your Lyophilization Questions Answered 7/8/2026

   Improve lyophilization outcomes by optimizing formulation, cycle parameters, and scale-up strategies to reduce variability and enhance stability across development.

10. Self-Amplifying RNA: The Next Chapter In mRNA Therapeutics 6/5/2026

    Self-amplifying RNA builds on mRNA technology by enabling intracellular replication, delivering stronger and longer-lasting responses at lower doses while improving scalability, cost-efficiency, and global accessibility.