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Articles

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  Two Molecules, One Test: What ADCs Demand from Identity Testing

  ADCs have changed the requirements for identity testing. Unlike conventional monoclonal antibodies, they require manufacturers to confirm two independently variable molecular components within a single therapeutic product while distinguishing that product from an increasingly complex portfolio of related molecules. (more…)

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  Biotherapeutic Identity Testing: From Novel Concept to Mission-Critical Manufacturing Requirement

  As biologics portfolios expand, identity testing has shifted from a regulatory checkbox to a mission-critical manufacturing risk — and the tools to manage it have never been more capable. (more…)

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  LFA vs ELISA: How to Choose the Right Diagnostic Method (Sensitivity, Speed & Use Case)

  Lateral flow assays (LFA) and enzyme-linked immunosorbent assays (ELISA) are widely used immunoassay techniques. Choosing the right method depends on application, sensitivity, and environment. Both methods have been around for over 50 years, and each has earned a well-deserved place in diagnostics. But they are not interchangeable — ELISA offers high sensitivity, while LFA provides rapid results. Understanding where each excels is critical to selecting the right tool for your application. (more…)