Biosimilars | Prolytix

Pharmacokinetics (PK)

Overview: Our PK assessments are critical for establishing bioequivalence between your biosimilar and its reference product. We provide detailed insights into absorption, distribution, metabolism, and excretion, ensuring your product performs as expected in the body.

Advanced Ligand Binding Assays: Utilizing ELISA and MSD-based immunoassays, we accurately quantify serum or plasma concentrations over time, capturing the full pharmacokinetic profile.
Key Considerations: Our assays are optimized to detect any subtle differences in exposure and clearance, which are essential for demonstrating biosimilarity.
Application Across Therapeutic Areas:
- Cancers: Ensures comparable tumor penetration and exposure, critical for therapeutic effectiveness.
- Autoimmune Diseases: Monitors distribution in inflammatory conditions to support consistent therapeutic levels.
- Infectious Diseases: Confirms rapid bioavailability and sustained exposure necessary for pathogen neutralization.

Immunogenicity

Overview: Immunogenicity testing is essential for confirming that your biosimilar does not provoke unwanted immune responses. Our assays ensure that any potential immunogenicity is within acceptable limits compared to the reference product.

Sensitive Bridging Immunoassays: We use advanced ELISA-based techniques to detect anti-drug antibodies (ADAs), ensuring early identification of any immunogenicity concerns.
Application Across Therapeutic Areas:
- Cancers: Continuous monitoring ensures that repeated dosing does not lead to adverse immune responses.
- Autoimmune Diseases: Critical for patients with dysregulated immune systems, minimizing the risk of additional immune activation.
- Infectious Diseases: Ensures that immune responses do not interfere with the biosimilar’s capacity to neutralize pathogens.

Biomarkers and Pharmacodynamics

Overview: Our biomarker assays provide insight into the biological activity and therapeutic impact of your biosimilar. By monitoring key indicators, we help demonstrate equivalence in mechanism of action.

Advanced Ligand Binding & Multiplex Assays: These platforms measure critical biomarkers such as cytokines, growth factors, and soluble receptors.
Key Considerations: Our assays are capable of distinguishing the biosimilar’s impact on signaling pathways and immune modulation compared to the reference product.
Application Across Therapeutic Areas:
- Cancers: Monitors tumor markers and immune checkpoint proteins to assess treatment response.
- Autoimmune Diseases: Evaluates inflammatory biomarkers to confirm consistent immune modulation.
- Infectious Diseases: Tracks host and pathogen-specific biomarkers to validate effective pathogen neutralization.

CMC Bioanalytical

Overview: Our CMC bioanalytical services ensure that your biosimilar is manufactured with consistent quality, matching the reference product in purity, structure, and stability.

Structural Integrity & Purity Analysis: Techniques such as SDS-PAGE, capillary electrophoresis (CE-SDS), and glycan profiling verify that the biosimilar is structurally identical and free from contaminants.
Stability & Aggregation Studies: We use Size-Exclusion Chromatography (SEC) and Dynamic Light Scattering (DLS) to monitor product stability and detect any aggregation, ensuring long-term quality.
Potency Assays: Functional assays confirm that the biosimilar retains the biological activity of the reference product.
Key Considerations: Our comprehensive CMC approach is tailored to address the inherent challenges in replicating a complex biological molecule, ensuring every critical quality attribute is met.
Application Across Therapeutic Areas:
- Cancers: Guarantees consistent performance, critical for high-risk patient populations.
- Autoimmune Diseases: Minimizes variability to prevent additional immune challenges.
- Infectious Diseases: Ensures rapid and reliable therapeutic action by maintaining product integrity.

Why Choose Our Analytical Platform?

Our expert team leverages advanced technologies and deep regulatory expertise to provide precise, actionable data that supports the successful development of biosimilars. With our comprehensive analytical services, you can confidently demonstrate biosimilarity and advance your product from development to market.