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Why Preclinical Formulation Analysis is Critical to Successful Drug Development

Preclinical studies are designed to establish the safety profile and biological activity of a therapeutic candidate before human testing can begin. The interpretation of these…

From Signals to Systems: Olink Proteomics as a Cornerstone of Synexa’s Biomarker Strategy

We have entered a new era of modern science, where therapeutic innovation is reshaping the field of medicine.…

GMP Grade Ligand Binding and Potency Assays – Frequently Asked Questions

Good Manufacturing Practice ligand binding and potency assays are essential for ensuring the quality, safety, and regulatory compliance of biopharmaceutical…

Validating Immunity: How ELISpot Data Shaped the AELIX-003 HIV Cure Trial

We are proud to share our laboratory’s role in a landmark clinical study published in Nature Communications, titled “Safety, immunogenicity…

From Pathways to Proof: Targeted Phosphoproteomics and PTM Analysis with LC-MS/MS

Quadrupole mass spectrometry (LC-MS/MS) has long established itself as the workhorse of bioanalysis for small molecules, valued for its high…

Establishing Biosimilarity: Regulatory and Scientific Expectations

A biosimilar is defined as a biologic product, highly similar to a reference or originator, with no clinically meaningful differences…

Why The Future Of Precision Medicine Will Be Defined By The Quality And Strategy Of Biomarker Signatures

We’re in the midst of a paradigm shift in biomarker science. No longer academic luxuries or exploratory afterthoughts, biomarker signatures…