Custom ELISA Development Services
At Fleet Bioprocessing Ltd., we specialise in immunoassay development and offer a comprehensive range of services for Enzyme-Linked Immunosorbent Assays (ELISAs). With our technical expertise and extensive experience, we are committed to providing cutting-edge solutions to meet the needs of our clients. We are a leading expert in ELISA development, catering to a wide range of sectors, including drug development, clinical diagnostics, veterinary diagnostics, defence diagnostics, and life science research. With a wealth of experience and a track record of successful projects, we are well-equipped to meet the unique challenges posed by diverse industries.
Our ELISA development service spans the entire process, offering a comprehensive solution for your ELISA project from initial conception to final product launch, our comprehensive services cover the entire journey. We also understand that project's requirements may vary, and customers may have their own specific requirements. As such we also provide select services to complement your existing capabilities, bolster your project and provide added proficiency where you need it most.
What Fleet Bioprocessing Ltd. can offer you
One of the most critical steps in ELISA development is antibody selection. At Fleet Bioprocessing Ltd., we understand the importance of selecting the right antibodies for your ELISA. Leveraging our extensive market knowledge, we can identify the best commercially available antibodies, or assist you in creating custom polyclonal or monoclonal antibodies. Subsequently, we construct prototype immunoassay formats to evaluate their suitability for your specific needs.
Before proceeding with full-scale development, we conduct rigorous proof-of-concept and feasibility studies to evaluate the potential success of your ELISA project. These studies help us identify any potential challenges and begin to optimise the assay design early in the development process.
With expertise in immunoassay development, we offer custom solutions to address analytical challenges. Whether you have comprehensive information or minimal information we can create custom ELISAs to support your research needs.
With our in-depth knowledge of immunoassays, we carry out optimisation procedures to enhance the performance of your ELISA. Through systematic adjustments, we strive to achieve optimal assay conditions for accurate and consistent results that match your project aims.
Ensuring the reliability and accuracy of ELISA results is crucial for clinical diagnostics. We conduct thorough performance verification studies to validate the assay's precision, accuracy, linearity, and sensitivity. Additionally, we provide claim support documentation to meet the regulatory requirements and demonstrate the clinical utility of your ELISA.
When your ELISA assay is ready for production, we facilitate a seamless transfer to manufacturing, ensuring a smooth transition from development to large-scale production. Our team is experienced in working with manufacturing partners to ensure quality and consistency throughout the process.
We believe in building long-term partnerships with our clients. Therefore, we offer post-launch support to address any potential issues and assist in optimising your assay's performance during its lifecycle as well as meeting new and evolving regulatory requirements. We offer theses services for both ELISAs developed by Fleet Bioprocessing Ltd. as well as existing assays that may need additional support.
At Fleet Bioprocessing Ltd. we offer specialised ELISAs for pharmaceutical development to address critical bioanalytical challenges. Our services include PK, PD, biomarker immunoassays, ADA, and other immunogenicity monitoring, as well as companion diagnostic including ELISAs tailored to support theranostics.
At Fleet Bioprocessing Ltd., we understand the significance of adhering to the highest quality and regulatory standards in the field of clinical diagnostics. We operate in accordance with the following standards:
ISO 9001:2015: This internationally recognised standard focuses on quality management systems and ensures that our processes are streamlined, efficient, and consistently deliver high-quality services.
ISO 13485:2016: This standard is specific to the medical device industry and outlines the requirements for a quality management system focused on the design, development, and manufacturing of medical devices, including in vitro diagnostic (IVD) products.
Diagnostic GMP Requirements of the Quality System Regulations of the US FDA: Our operations comply with the strict quality standards set forth by the US Food and Drug Administration (FDA) to ensure the safety and effectiveness of diagnostic products.
At Fleet Bioprocessing Ltd., we are committed to providing ELISA development services that meets the highest industry standards and regulatory requirements. Our team's expertise in antibody selection, optimisation, performance verification, and more, makes us the ideal partner for your immunoassay development needs. Whether you are a global market leader, an academic researcher, a spin-out, or an SME, we have the experience and capabilities to deliver successful outcomes for your project needs. Reach out to us via our enquiry form to discuss your immunoassay development needs and how we can support you in achieving your goals.
Example Projects
From conception to launch - novel cancer marker ELISA
Fleet Bioprocessing Ltd. partnered with a UK start-up to develop an innovative immunoassay for pancreatic cancer, leveraging a newly discovered biomarker. Our end-to-end support encompassed claim support, stability trials, and securing CE marking for the assay's successful launch. Additionally, we manufactured the initial launch batches and continue to provide crucial reagents, ensuring the ongoing success of this research ELISA with limited starting material.
Research applications - EU wide collaboration
Fleet Bioprocessing Ltd. played a crucial role in the BiomarCaRe project, part of the EC-funded Framework 7 program, where we took on the task of developing novel ELISAs for potential cardiovascular risk indicators. Using only analytes discovered from transcriptomics studies where antigens and antibodies were commercially unavailable we were able to develop a number of successful assays.
Support for existing assays
When a global diagnostics company encountered stability challenges with their assay calibrators, Fleet Bioprocessing Ltd. was able to provide the help they needed. Through an in-depth reformulation study, we utilised our expertise and extensive literature review to identify alternative matrices and protective additives. This resulted in significantly improved stability in their assays, enabling the transition from lyophilised or frozen to ready-to-use calibrators.