Recombinant Proteins

Pharmacokinetics (PK)

Overview: Our PK analyses focus on characterizing the absorption, distribution, metabolism, and excretion of recombinant proteins. This information is essential for optimizing dosing strategies and ensuring that the therapy reaches its intended targets at effective concentrations.

Advanced Ligand Binding Assays: Utilizing ELISA and MSD-based immunoassays, we accurately measure serum or plasma concentrations over time, ensuring robust PK profiles.
Key Considerations: Our assays are optimized to detect both full-length proteins and any degradation products, which is critical for establishing bioequivalence and optimizing clinical dosing.
Application Across Therapeutic Areas:
- Cancers: Ensures proper distribution and retention within the tumor microenvironment.
- Autoimmune Diseases: Monitors pharmacokinetic profiles in inflammatory settings to maintain steady therapeutic levels.
- Infectious Diseases: Confirms rapid bioavailability and sustained exposure necessary for pathogen neutralization.

Immunogenicity

Overview: Immunogenicity testing is critical for recombinant protein therapies to ensure they do not trigger unwanted immune responses. Our assays detect and quantify anti-drug antibodies (ADAs) that may affect therapeutic efficacy and safety.

Sensitive Bridging Immunoassays: We utilize ELISA-based techniques to accurately detect ADAs, ensuring early identification of potential immunogenicity issues.
Key Considerations: Our protocols are designed to detect even low levels of immunogenicity, providing a detailed risk profile that supports regulatory requirements.
Application Across Therapeutic Areas:
- Cancers: Continuous treatment necessitates stringent immunogenicity monitoring to prevent therapeutic neutralization.
- Autoimmune Diseases: Ensures that the therapy does not exacerbate underlying immune dysregulation.
- Infectious Diseases: Verifies that immunogenic responses do not compromise pathogen neutralization.

Biomarkers and Pharmacodynamics

Overview: Biomarker assays offer critical insights into the therapeutic impact of your recombinant proteins. By monitoring relevant biomarkers, we can validate target engagement and link therapeutic activity to clinical outcomes.

Advanced Ligand Binding & Multiplex Assays: Our platforms measure key biomarkers such as cytokines, growth factors, and soluble receptors.
Key Considerations: These assays are designed to capture subtle changes in biomarker levels that indicate efficacy and mechanism of action.
Application Across Therapeutic Areas:
- Cancers: Tracks tumor markers and immune response indicators for effective treatment monitoring.
- Autoimmune Diseases: Evaluates shifts in inflammatory mediators to gauge immune modulation.
- Infectious Diseases: Monitors host and pathogen-specific biomarkers to confirm the therapeutic impact on infection control.

CMC Bioanalytical

Overview: Our CMC bioanalytical services are designed to ensure that your recombinant protein therapy is manufactured with consistent quality. We verify that your product maintains structural integrity, purity, and biological activity throughout its lifecycle.

Structural Integrity & Purity Analysis: Techniques such as SDS-PAGE, capillary electrophoresis (CE-SDS), and glycan profiling confirm that the recombinant protein is correctly folded and free of contaminants.
Stability & Aggregation Studies: We use Size-Exclusion Chromatography (SEC) and Dynamic Light Scattering (DLS) to monitor product stability and detect any aggregation or degradation over time.
Potency Assays: Functional assays validate that the recombinant protein retains its intended biological activity.
Key Considerations: Our comprehensive CMC approach is tailored to address the inherent challenges of recombinant protein production, ensuring consistent quality from production through clinical application.
Application Across Therapeutic Areas:
- Cancers: Guarantees product consistency crucial for effective cancer therapies.
- Autoimmune Diseases: Ensures that the recombinant protein performs reliably, reducing the risk of variable immune responses.
- Infectious Diseases: Maintains high quality standards to support rapid and effective pathogen neutralization.

Why Choose Our Analytical Platform?

Our expert team leverages state-of-the-art technologies and deep industry expertise to provide precise, actionable data. With our comprehensive analytical services, you can confidently advance your recombinant protein therapies from development to clinical success. Let us help you optimize dosing strategies, monitor therapeutic outcomes, and ensure the highest standards of product quality.