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GMP Potency Assays: Technologies & Validation Guide

Following up on our previous GMP blog “GMP Grade Ligand Binding and Potency Assays – Frequently Asked Questions”, this article explores GMP potency assays, including…
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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…
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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…
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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…
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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…
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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…
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Radiopharmaceutical Drug Development: A Bioanalytical Lab Perspective

The radiopharmaceutical industry has traditionally experienced steady but modest growth, primarily driven by its established role in diagnostics and nuclear…
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