At Creative Biolabs, our core strength lies in comprehensive IVD kit development. Backed by decades of collective expertise and a legacy of hundreds of successfully developed and commercialized immunoassay kits, our scientists are masters of diverse assay formats. Whether you require ELISA, lateral flow, or advanced detection platforms, our high-performance formulations offer a quicker, more reliable path to commercialization. Leveraging newly developed antibodies and antigens, coupled with state-of-the-art facilities, we consistently deliver the most sensitive and reproducible immunodiagnostic kits globally.
Core IVD Kit Development Services
Enzyme-Linked Immunosorbent Assay (ELISA)
ELISA remains a cornerstone in diagnostics, given its high sensitivity and specificity. We excel in developing various ELISA formats, including direct, indirect, sandwich, and competitive assays. Our service encompasses everything from antigen/antibody pair selection and optimization to conjugation strategies, substrate selection, and comprehensive buffer system development, ensuring robust and reproducible results for target analytes like infectious disease markers, hormones, tumor markers, and therapeutic drug monitoring.
Lateral-Flow Immunochromatographic Assay (LFIA)
LFIA kits, commonly known as rapid tests, are pivotal for point-of-care diagnostics given their speed, simplicity, and portability. Creative Biolabs offers end-to-end LFIA development, covering membrane selection, conjugate pad treatment, antibody/antigen spraying, and overall strip design. We focus on optimizing signal intensity, reducing non-specific binding, and enhancing shelf-life to deliver highly sensitive and specific rapid diagnostic solutions for applications ranging from infectious diseases to pregnancy tests and drug detection.
Latex particle-enhanced Turbidimetric Immunoassay (LETIA)
LETIA kits utilize latex particles coated with antibodies or antigens to amplify the turbidimetric signal upon analyte binding, enabling quantitative measurements. Our development focuses on particle optimization, conjugation chemistry, and precise calibration to achieve high sensitivity and wide detection ranges. These kits are particularly valuable for clinical chemistry analyzers, offering automated, high-throughput testing for analytes like C-reactive protein (CRP) and D-dimer.
Western Blot (WB)
WB based kits are indispensable for confirming the presence of specific proteins and are frequently used as confirmatory tests for infectious diseases or autoimmune conditions. Creative Biolabs provides services for developing all components of a WB kit, including optimized antigen preparation, high-quality primary and secondary antibodies, blocking buffers, and detection reagents. Our rigorous optimization ensures clear banding patterns, minimal background, and reliable qualitative results.
Immunohistochemistry (IHC)
IHC kits are crucial for visualizing specific antigens in tissue sections, playing a vital role in pathology, cancer diagnostics, and research. Our IHC kit development encompasses primary antibody validation, chromogenic or fluorescent detection systems, antigen retrieval protocols, and counterstains. We focus on optimizing every step to ensure strong, specific staining, clear morphological detail, and consistent performance for accurate histological assessment.
Flow Cytometry (FC)
FC based kits allow for the rapid, quantitative analysis of cells or particles in suspension, making them essential for immunology, hematology, and oncology. Creative Biolabs develops multi-parameter FC kits, including antibody panels, isotype controls, and staining buffers. Our expertise ensures optimal fluorophore conjugation, compensation strategies, and validation for accurate cell population identification, phenotyping, and functional analysis.
Microplates Coating
The quality of coated microplates is fundamental to the performance of many immunoassays. We offer specialized microplate coating services, ensuring uniform and stable immobilization of antigens or antibodies. We offer plates of different sizes and formats. Our processes are optimized for various coating methods and protein types, minimizing variability and maximizing binding capacity while reducing non-specific adsorption, thus providing a critical foundation for highly reliable ELISA and other plate-based assays.
Typical Project Workflow
At Creative Biolabs, our custom IVD kit development service follows a streamlined, phased workflow. This structured approach efficiently transforms your diagnostic concept into a high-performance, market-ready product, prioritizing scientific rigor and regulatory compliance from inception.
Discovery and Design
This initial phase involves thorough consultation to grasp your project's objectives, target analyte, and performance requirements. We conduct feasibility studies for selected biomarkers and conceptualize the optimal assay format. This critical step defines the kit's specifications and creates a clear development path.
Assay Development and Optimization
Here, we transition from concept to practical execution. Our team meticulously selects and develops high-quality reagents, including specific antibodies or antigens. Extensive experiments optimize assay conditions to ensure high sensitivity, specificity, and robust performance across various sample types, delivering a refined prototype.
Validation and Documentation
With an optimized assay prototype, rigorous analytical validation is performed to confirm performance parameters like sensitivity, specificity, and precision. This also includes essential clinical validation studies to demonstrate clinical utility. Simultaneously, comprehensive documentation, including detailed protocols and risk management files, is prepared for regulatory submissions.
Manufacturing Transfer and Regulatory Support
The final stage focuses on seamless process transfer to a cGMP-compliant manufacturing environment, ensuring scalability and consistent product quality. We assist in defining critical quality control procedures. Our regulatory specialists provide vital support in compiling technical documentation and navigating submission pathways, accelerating your kit's journey to market authorization.
Features of Our Services
- Tailored Development Pathways: Bespoke solutions are crafted, adapting extensive expertise to each client's unique scientific and commercial needs. This approach ensures every kit is optimized for its specific application, from initial concept to commercialization.
- High-Performance Reagent Engineering: Proprietary technologies and deep experience are leveraged to develop and source ultra-specific, high-affinity antibodies and antigens. Superior raw materials are fundamental to achieving unmatched sensitivity and specificity in your IVD kit.
- Integrated Regulatory Foresight: Development processes are designed with global regulatory compliance in mind from day one. Proactive incorporation of design controls and risk management significantly streamlines technical file compilation, accelerating your pathway to regulatory approvals.
- Robust Quality Assurance: Stringent quality management systems and rigorous testing protocols are implemented throughout the development lifecycle, ensuring every IVD kit meets the highest standards of performance, reproducibility, and safety.
Q&A
-
Q: How long does typical IVD kit development take at Creative Biolabs?
A: IVD kit development timelines vary significantly, typically ranging from 12 to 36 months. This depends on the kit's complexity, biomarker novelty, and specific regulatory pathway. Simpler immunoassay kits generally have shorter cycles, while complex panels require more extensive development and validation. We establish realistic timelines collaboratively.
-
Q: Can you develop IVD kits for novel or challenging biomarkers?
A: Yes, we specialize in challenging projects, including novel or hard-to-detect biomarkers. Our expert scientists leverage deep knowledge in protein engineering and antibody generation to overcome issues like low concentration or instability. Advanced strategies and innovative detection methods achieve robust performance for unique diagnostic targets.
-
Q: Can you scale up manufacturing of developed IVD kits?
A: We primarily focus on IVD kit research, development, and validation for commercial readiness. While we don't handle large-scale commercial manufacturing directly, we specialize in seamlessly transferring the validated process to your chosen manufacturing partner or a suitable contract manufacturing organization (CMO). Our documentation facilitates efficient tech transfer.
-
Q: What documentation is supplied upon project completion?
A: Upon completion, clients receive a comprehensive suite of documentation vital for regulatory submissions and future manufacturing. This includes detailed development reports, analytical and clinical validation summaries, reagent specifications, optimized assay protocols, stability data, and a risk management file, ensuring full traceability.
-
Q: Do you offer post-launch support or troubleshooting?
A: Yes, we support clients post-market launch. We offer various levels of post-launch support, including technical consultation for troubleshooting, assistance with minor product modifications, and ongoing regulatory guidance for post-market surveillance. Our purpose is to assure the continued success and performance of your diagnostic product.
The technical team at Creative Biolabs is highly skilled in IVD kit development. Using novel techniques and formulations, they are often able to overcome obstacles in development and build robust, reproducible assays for our clients. If you are interested in any of our services or have a specific assay that you want to develop, please contact us and we would be happy to help. Our knowledgeable team will be able to provide you with a highly competitive quote with realistic turnaround times.
For Research Use Only.
