top of page
UKCA and IVDR
As of January 2025, the UK government has provided updated guidance on the regulatory requirements for in vitro diagnostic medical...
Feb 11
Biomarker Assay Development and Validation: Ensuring Reliability in Clinical Applications
Biomarkers have become essential tools in modern medicine, providing critical insights into disease states, treatment efficacy, and...
Oct 3, 2024
FDA's QMSR and Synchronization with ISO 13485:2016: Insights from Document 89 FR 7496
In medical device regulation, the adherence to stringent quality management standards is pivotal. Regulatory bodies such as the U.S. Food...
Aug 12, 2024
Verification vs. Validation in Immunoassay and In Vitro Diagnostics
In the field of immunoassays and in vitro diagnostics (IVD), ensuring the accuracy and reliability of tests is paramount. These...
Jul 19, 2024
Harnessing Bioconjugation for Therapeutic Advancements
In modern medicine, the field of bioconjugation has emerged as a powerful tool for advancing therapeutic applications. By combining...
Jul 10, 2024
Navigating the Sensitivity vs. Specificity Dilemma in In Vitro Diagnostics
In vitro diagnostics (IVD) are pivotal tools in healthcare, aiding in disease diagnosis, monitoring, and treatment decisions. However,...
Jul 3, 2024
Quality Control in Immunoassay Development to Ensure Reliable Results
In the realm of biomedical research and clinical diagnostics, immunoassays play a pivotal role in detecting and quantifying biomolecules...
Jun 11, 2024
Scope Creep from IVDR into Regulated Bioanalysis
As industries evolve, so do regulations governing them. The In Vitro Diagnostic Regulation (IVDR) was introduced to enhance the safety...
May 17, 2024
Understanding the FDA's new regulations for Lab Developed Tests (LDTs)
In the realm of modern medicine, diagnostic tests play a pivotal role in identifying and treating diseases. As technology advances, so...
May 9, 2024
Navigating Challenges in the Development of ADA Assays for Immunogenicity Studies
In the realm of biopharmaceutical development, understanding and mitigating the immunogenicity of therapeutic proteins is crucial for...
Apr 23, 2024
Choosing the Right Platform for ADA Assays in Immunogenicity Studies: A Critical Decision
In the realm of biopharmaceutical development, understanding and mitigating the immunogenicity of therapeutic proteins is paramount....
Apr 5, 2024
Streamlining Success: The Compelling Reasons to Outsource Bioconjugation and Antibody Labelling
In the dynamic landscape of life sciences and diagnostics, bioconjugation and antibody labelling stand as critical processes in advancing...
Feb 26, 2024
Unlocking Efficiency: Reasons to Outsource Immunoassay and ELISA Development
In the rapidly evolving landscape of life sciences and diagnostics, immunoassays and ELISAs play a pivotal role in detecting and...
Jan 31, 2024
The Crucial Role of ISO 13485 Accreditation in Elevating In Vitro Diagnostic Development
Introduction: In the realm of medical devices, particularly in vitro diagnostics (IVD), ensuring the highest standards of quality,...
Jan 8, 2024
The Importance of Expert Witness Testimony
Recently, one of Fleet Bioprocessing’s experts was asked to consult on a project. Nothing unusual about that, Fleet experts regularly act...
Dec 6, 2023
Antibody-Drug Conjugates and the Imperative for Reproducible Conjugation Methods
One of the most notable recent innovations in the field of medical science is the development of Antibody-Drug Conjugates (ADCs). ADCs...
Dec 1, 2023
Your Premier Partner for Gyrolab Assay Reagents
At Fleet Bioprocessing Ltd., we take pride in being a Gyrolab Certified Assay Transfer and Development Partner. Fleet Bioprocessing Ltd....
Nov 21, 2023
The Role of Education at Fleet Bioprocessing
At Fleet Bioprocessing we believe in the power of education and its role in shaping the next generation of talented scientists. Through...
Sep 11, 2023
8 critical tips to consider when developing and optimising an immunoassay or ELISA.
Optimising an ELISA method involves several steps to enhance the accuracy, sensitivity, specificity, and overall performance of the...
Jul 25, 2023
Fleet contribute to Structure-Function Metrology of Proteins
Fleet Bioprocessing Ltd collaborated the National Physical Laboratory and the National Measurement Laboratory (at LGC Ltd) on a project...
Mar 27, 2023
bottom of page