Biosimilar Development solution center
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Do Changes Signal The End Of Biosimilar Regulatory Redundancy?
4/23/2026
First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.
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ADC Development Grows More Complex — SPR Insights Bring Clarity
4/14/2026
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.