Biomarker Assay Development and Validation: Ensuring Reliability in Clinical Applications
FDA's QMSR and Synchronization with ISO 13485:2016: Insights from Document 89 FR 7496
Verification vs. Validation in Immunoassay and In Vitro Diagnostics
Harnessing Bioconjugation for Therapeutic Advancements
Navigating the Sensitivity vs. Specificity Dilemma in In Vitro Diagnostics
Quality Control in Immunoassay Development to Ensure Reliable Results
Scope Creep from IVDR into Regulated Bioanalysis
Understanding the FDA's new regulations for Lab Developed Tests (LDTs)
Navigating Challenges in the Development of ADA Assays for Immunogenicity Studies
Choosing the Right Platform for ADA Assays in Immunogenicity Studies: A Critical Decision
Streamlining Success: The Compelling Reasons to Outsource Bioconjugation and Antibody Labelling
Unlocking Efficiency: Reasons to Outsource Immunoassay and ELISA Development
The Crucial Role of ISO 13485 Accreditation in Elevating In Vitro Diagnostic Development
The Importance of Expert Witness Testimony
Antibody-Drug Conjugates and the Imperative for Reproducible Conjugation Methods
Your Premier Partner for Gyrolab Assay Reagents
The Role of Education at Fleet Bioprocessing
8 critical tips to consider when developing and optimising an immunoassay or ELISA.
Fleet contribute to Structure-Function Metrology of Proteins
Critical reagents for ligand binding assays