Bi- and Tri-Specific Antibodies

Pharmacokinetics (PK)

Overview: Understanding the journey of your multi-specific protein within the body is critical. Our PK analyses provide detailed insights into absorption, distribution, metabolism, and excretion, ensuring that your therapeutic reaches its target effectively.

Advanced Ligand Binding Assays: We utilize ELISA and MSD-based immunoassays that are optimized to capture the complexity of multi-domain molecules. These assays measure plasma or serum concentrations over time, providing accurate pharmacokinetic profiles.
Key Considerations: Given the multi-target nature, our assays are carefully calibrated to detect full-length proteins and differentiate them from any fragments. This is crucial for establishing proper dosing regimens.
Application Across Diseases:
- Cancers: Ensures sufficient exposure in the tumor microenvironment where tissue penetration and vascular permeability can be challenging.
- Autoimmune Diseases: Adjusts for altered distribution in inflammatory conditions to maintain effective therapeutic levels.
- Infectious Diseases: Verifies rapid bioavailability and sustained exposure necessary for timely pathogen neutralization.

Immunogenicity

Overview: The complex architecture of bi- and tri-specific proteins can introduce immunogenic risks. Our robust immunogenicity testing ensures that your therapeutic does not provoke unwanted immune responses that could compromise efficacy or safety.

Sensitive Bridging Immunoassays: We employ highly sensitive ELISA-based methods designed to detect anti-drug antibodies (ADAs) directed against any of the binding domains.
Key Considerations: With multiple binding sites, our assays are optimized to separately evaluate the immunogenicity of each domain, offering a detailed risk profile.
Application Across Diseases:
- Cancers: Continuous dosing requires stringent ADA monitoring to prevent therapeutic neutralization.
- Autoimmune Diseases: Enhanced risk in dysregulated immune systems is mitigated through early and precise immunogenicity assessment.
- Infectious Diseases: Ensures that immune responses do not hinder pathogen neutralization and maintain effective therapeutic levels.

Biomarkers and Pharmacodynamics

Overview: Our biomarker assays provide critical insights into the biological impact of your therapeutic. By monitoring changes in key indicators, we help validate target engagement and therapeutic efficacy.

Advanced Ligand Binding & Multiplex Assays: These technologies are used to measure circulating biomarkers, such as cytokines, soluble receptors, and tumor antigens.
Key Considerations: Our assays are designed to differentiate between the effects of each binding domain, ensuring that you get a complete picture of your therapeutic’s mechanism of action.
Application Across Diseases:
- Cancers: Tracks changes in tumor antigens and immune checkpoints, providing real-time insights into treatment response.
- Autoimmune Diseases: Monitors inflammatory markers to evaluate the modulation of immune responses.
- Infectious Diseases: Assesses host and pathogen-derived biomarkers to confirm effective pathogen neutralization.

CMC Bioanalytical

Overview: Ensuring the quality and consistency of your bi- or tri-specific antibody therapeutic is paramount. Our CMC bioanalytical services verify that your product meets the highest standards of purity, stability, and functionality throughout its lifecycle.

Structural Integrity & Purity Analysis: Utilizing SDS-PAGE, CE-SDS, and glycan profiling, we confirm the correct assembly and purity of the multi-domain protein.
Stability & Aggregation Studies: Size-Exclusion Chromatography (SEC) and Dynamic Light Scattering (DLS) are employed to monitor aggregation and degradation, ensuring long-term product stability.
Potency Assays: Functional cell-based tests are used to confirm that each binding domain remains active, maintaining the therapeutic’s intended multi-target efficacy.
Key Considerations: Our comprehensive CMC approach is specifically tailored to manage the complexities of multi-specific proteins, ensuring consistent quality from production through storage.
Application Across Diseases:
- Cancers: Guarantees product consistency, critical for high-risk patient populations.
- Autoimmune Diseases: Minimizes variability to avoid unintended immune stimulation.
- Infectious Diseases: Ensures rapid, reliable pathogen neutralization by maintaining the integrity of all binding domains.

Why Choose Our Analytical Platform?

Our dedicated team of experts leverages cutting-edge technology and deep industry expertise to deliver precise, actionable data. With our comprehensive analytical services, you can confidently advance your bi- and tri-specific antibody therapeutics from the lab to clinical application. Let us help you optimize dosing strategies, monitor patient responses, and ensure the highest standards of product quality.