IVD Antibody Development Platform

Creative Biolabs provides comprehensive custom antibody development services, encompassing both monoclonal and polyclonal antibody generation. Our dedicated IVD Antibody Development Service transcends conventional approaches, delivering highly specific, sensitive, and robust antibodies tailored for the demanding environment of diagnostic applications. We specialize in producing and validating antibodies against a diverse range of biomarker proteins relevant to key research areas, including oncology, neurobiology, immunology, and infectious diseases. The process culminates in the production of stable, reproducible antibodies, validated for their intended use and scalable for commercial manufacturing, laying a solid foundation for your diagnostic kits. Our tailored custom antibody development services include:

• Peptide design, synthesis, and conjugation to generate antibodies with optimized affinity and specificity.
• Monoclonal antibody generation in various host species, such as mouse, rat, hamster, and others, to meet specific experimental requirements.
• Polyclonal antibody production utilizing a wide array of host species.
• Development of matched antibody pairs (mAb-mAb, mAb-pAb, and pAb-pAb) specifically for ELISA assay development.
• Custom antibody development utilizing both hybridoma and phage display technologies.
• Production of recombinant antibodies, including full-length formats (with species and isotype switching) and partial-length fragments (e.g., scFv, Fab, F(ab)2, BsAb).
• Antibody variable region cloning and sequencing, humanization, and optimization.
• Comprehensive peptide and antibody purification services employing both traditional and custom affinity methodologies.

Creative Biolabs has specialized expertise in antibody and protein conjugation to offer specialized conjugation services, transforming raw antibodies or proteins into ready-to-use, assay-optimized components. This precision labeling ensures optimal signal generation and stability across different immunoassay platforms like ELISA, lateral flow, or chemiluminescence assays. Whether seeking modifications to our proprietary antibodies or custom conjugation of client-supplied antibodies, our integrated approach guarantees that your conjugated reagents maintain peak performance, streamlining your downstream development and accelerating time to market for your diagnostic products. Our comprehensive conjugation services encompass:

• Custom conjugation of peptides, antibodies, or other proteins to a broad spectrum of molecules, including haptens, carrier proteins, various labels, and effector enzymes.
• An extensive selection of conjugates and labels, ranging from protein-protein complexes and particle conjugates to biotin, a wide array of fluorochromes, and specialized detection tags.
• A complete service workflow that includes meticulous labeling, purification, and comprehensive characterization of the final conjugated product.
• Expert consultation providing comprehensive advice on optimal labeling strategies and precise reaction design to achieve specific research objectives.

The era of personalized medicine is here, driven by the critical role of companion diagnostics. Creative Biolabs is at the forefront of this revolution, offering specialized CDx development services that perfectly align with targeted therapeutic strategies. We understand the stringent regulatory and scientific demands unique to CDx assays, which often co-develop with novel pharmaceuticals. Our platform is adept at identifying and developing high-performance antibodies for protein-based biomarkers, essential for guiding therapeutic decisions across oncology, autoimmune conditions, and other critical disease areas. From initial biomarker validation and antibody discovery to providing materials suitable for rigorous clinical trials and eventual regulatory submission, our integrated approach ensures your CDx program progresses efficiently and reliably.

While our core expertise is antibody development, Creative Biolabs recognizes that our products are integral to complete IVD immunoassay systems. Our platform is meticulously designed with an understanding of the broader immunoassay development lifecycle. We produce antibodies that are not just high-quality reagents but are truly "assay-ready," optimized for seamless integration into various diagnostic formats. Whether you are developing complex chemiluminescence assays, rapid lateral flow tests, traditional ELISA systems, or turbidimetric assays, our team's deep knowledge of immunoassay design and performance ensures that our antibodies provide the robust foundation you need. We collaborate closely with clients to ensure our antibody solutions contribute to their overall assay design, raw material selection, and systematic evaluation and optimization, thereby accelerating the entire development workflow.