Biosimilar Development solution center

  1. Building Trust In AI For Computerized System Validation 9/4/2026

    Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

  2. A Gentler Cell Line Selection Method Using microRNA 9/4/2026

    Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.

  3. Developing Non-PEG Stabilizer Lipids For Nucleic Acid Lipid Nanoparticles 7/1/2026

    Non-PEG stabilizer lipids may offer a new path for LNP design. Combining strong colloidal performance with greater chemical flexibility helps address growing concerns around PEG-related immunogenicity.

  4. Neoantigen-Based Personalized Cancer Vaccine 7/1/2026

    Personalized cancer vaccines are advancing quickly, but effective delivery remains a major hurdle. Learn how mRNA and lipid nanoparticle design influence targeting, endosomal escape, and repeat dosing.

  5. Lipid Nanoparticles For Pulmonary Delivery Of mRNA 7/1/2026

    Gain insight into how nebulized mRNA lipid nanoparticles show preclinical success in lung delivery, offering fresh momentum for inhaled gene therapies targeting respiratory diseases.

  6. Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines 6/30/2026

    Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

  7. The Invaluable Asset Driving Advanced Therapies Forward 6/19/2026

    Cell therapies are advancing rapidly, but manufacturing delays still limit patient access. Improving operational understanding, reducing risk, and strengthening collaboration may be just as critical.

  8. A Custom Path To The Clinic: Inside A Collaborative Model 6/19/2026

    Balancing speed, compliance, and control is no small task. A different approach to external support is emerging—one that prioritizes knowledge transfer, collaboration, and long-term confidence.

  9. Collaborative Supply Chain Management In A Fragmented World 6/15/2026

    Biopharma supply chains are under pressure. As regionalization accelerates, success depends on agility, trust, and new approaches to collaboration that can withstand ongoing global uncertainty.

  10. What To Do About Process Drift In Your Biosimilar's Reference Product 5/22/2026

    Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs.