The LBA is a straightforward and robust method for assessing an antibody's binding capability to its specific target. This assay utilizes a recombinant antigen or target as a ligand, allowing for real-time monitoring and analysis of binding activities. It provides essential kinetic data, including pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) parameters. All LBA services are conducted in GLP-compliant laboratories, adhering strictly to regulatory guidelines to ensure data integrity and reliability.
Binding Assays
Overview
Binding assays are essential tools in the development of therapeutic antibodies, serving a critical role in satisfying regulatory requirements set by agencies. These assays are crucial for quantifying the interaction between antibodies and their specific targets, providing vital insights into a drug's functional profile. Beyond simply evaluating affinity, binding assays contribute significantly to assessing potential immunogenicity (the propensity to elicit an immune response) and cytotoxicity. Therefore, establishing and validating highly robust and sensitive binding assay strategies is paramount throughout the entire antibody drug discovery and development pipeline.
Fig.1 An illustration of the development of antibody-based cancer therapy medications.1
Binding Assays by Creative Biolabs
Creative Biolabs stands as a leading innovator in therapeutic antibody development, offering an extensive suite of functional assays designed to elucidate antibody bioactivity and their mechanisms of action. Our specialized binding assay services are indispensable for precisely quantifying antibody-target interactions and generating comprehensive functional profiles, a critical requirement for therapeutic antibodies as mandated by regulatory bodies such as EMA. These assays are fundamental for evaluating affinity, assessing immunogenicity, and determining cytotoxicity throughout the antibody drug discovery and development pipeline.
Cell-Based Binding Assay
The Cell-Based Binding Assay serves as a vital complement to the LBA, proving indispensable for precisely determining an antibody's exact mechanism of action. Regulatory agencies increasingly require that cell-free LBA results be validated in a cell-based format to provide a more physiologically relevant assessment of antibody potency and bioactivity. Cell-Based Binding Assay offers distinct advantages, such as preserving the native conformation of the target and exhibiting higher sensitivity to physiochemical changes. Creative Biolabs provides a comprehensive portfolio of Cell-Based Binding Assay services for characterizing antibody-target interactions within living whole cells or cell lysates.
Antibody Cross-Reactivity Testing Service
Creative Biolabs offers essential antibody cross-reactivity testing to detect any unintended binding of therapeutic or diagnostic antibodies to non-target human tissues. This crucial preclinical assessment, vital for clinical application, is delivered using a variety of advanced testing technologies to support clients globally.
Our Service Workflow: From Concept to Clinical
1. Project Consultation & Design: Initial discussion to understand client objectives, target characteristics, and antibody properties, leading to the selection of appropriate assay formats and parameters.
2. Antigen/Target Preparation: Preparation or acquisition of high-quality recombinant antigens, cell lines, or tissue samples.
3. Antibody Preparation: Ensuring the therapeutic or diagnostic antibody is properly prepared and characterized for the assay.
4. Assay Setup & Execution: Performing the chosen binding assay (e.g., ELISA, SPR, BLI, cell-based assays) under controlled conditions, including appropriate controls and replicates.
5. Data Acquisition & Analysis: Collecting and processing raw data using advanced detection systems (e.g., plate readers, SPR instruments). and interpreting results to provide meaningful insights into antibody-target interactions.
6. Reporting: Delivering comprehensive reports detailing methodologies, raw data, analyzed results, and conclusions, often in GLP-compliant formats.
Our Advanced Binding Assay Platform
Leveraging profound expertise and extensive experience, Creative Biolabs has established a cutting-edge binding assay platform. This platform integrates multiple state-of-the-art techniques, enabling the provision of diverse assay formats tailored to specific research needs. Key technical approaches include:
|
|
|
|
|
|
|
|
Service Highlights
Expertise and Experience
Benefit from our extensive knowledge and years of experience in therapeutic antibody development and functional assay design.
State-of-the-Art Platform
Access to a cutting-edge binding assay platform integrating multiple advanced techniques for diverse assay formats.
Regulatory Compliance
All services are conducted in GLP-compliant laboratories, ensuring data integrity and adherence to strict regulatory guidelines.
Comprehensive Solutions
From non-cell-based to cell-based assays, and specialized services like cross-reactivity testing and custom assay design, we offer a full spectrum of solutions.
High-Quality, Reproducible Results
Our meticulous workflow and rigorous quality control ensure compelling and reproducible outcomes, providing absolute confidence for your investigations.
Customization
Our experts are specialized in designing and performing high-quality custom assays tailored to your specific requirements.
Frequently Asked Questions
-
Q1: How do you determine the best detection method for binding assays?
A1: The selection of the optimal detection method for binding assays is influenced by several factors, including the type of plate reader available, overall costs, and labeling expenses. Our plate readers support various detection modes such as fluorescence, luminescence, and absorbance. While all are viable, fluorescence-based assays are frequently favored due to their ability to produce intense and highly specific signals. It's also crucial to account for any potential signal variability that might arise from different compounds present in your samples when making this critical choice.
-
Q2: Can Creative Biolabs design custom binding assays?
A2: Yes, our experienced experts specialize in designing and performing high-quality custom assays. We can tailor assays with different formats, endpoints, and parameters to satisfy any specific client requirement.
-
Q3: What are the primary types of binding assays offered by Creative Biolabs?
A3: Creative Biolabs primarily offers two types of binding assays: Non-Cell-Based Ligand-Binding Assays (LBA) and Cell-Based Binding Assays. LBA is a robust method for evaluating antibody binding to specific targets using recombinant antigens, while Cell-Based Binding Assay complements LBA by assessing antibody potency and bioactivity in a more physiologically relevant, cell-based environment.
Related Services
Creative Biolabs also offers a variety of related services that complement their binding assay capabilities, such as:
- Angiogenesis Investigation
- Neutralization Assays
- Membrane Protein-targeted Antibody Functional Assays
- In Vitro Cellular Senescence Assay
If you are interested in our binding assays and want to evaluate your candidates' binding capacity to specific targets, please don't hesitate to get in touch with us.
Reference
- Lu, Ruei-Min et al. "Development of therapeutic antibodies for the treatment of diseases." Journal of biomedical science vol. 27.1 (2020): 1. doi:10.1186/s12929-019-0592-z. Distributed under Open Access License CC BY 4.0, without modification.
For Research Use Only.
Online Inquiry