Bioavailability & Biosimilarity Testing

Understanding a drug’s bioavailability and demonstrating biosimilarity are critical steps in drug development, ensuring that new therapeutics perform effectively and meet regulatory standards. At WaveCyte BioLabs, we provide analytical services to evaluate drug absorption, distribution, and comparability with reference products, empowering you with the data needed for confident regulatory submissions.

Our Bioavailability & Biosimilarity Testing Services

Bioavailability Studies: Quantify drug absorption and distribution to evaluate therapeutic performance and optimize dosing strategies.

Pharmacokinetic Profiling: Analyze ADME (absorption, distribution, metabolism, and excretion) properties for precise pharmacokinetic (PK) and pharmacodynamic (PD) data.

Comparability Assessments: Compare structural and functional characteristics of biosimilars to reference biologics using advanced techniques such as mass spectrometry and SPR.

Immunogenicity Testing: Assess immune responses to biosimilars and novel therapeutics, including detection of anti-drug antibodies (ADAs).

Structural Characterization: Employ state-of-the-art techniques like Circular Dichroism (CD), LC-MS/MS, and glycan profiling to confirm molecular similarity.

Potency Assays: Evaluate the functional activity of biosimilars and biologics to ensure equivalent therapeutic efficacy.

Stability Testing: Assess long-term stability and batch-to-batch consistency of biosimilars under various conditions.

What Is Bioavailability Testing

Bioavailability refers to the extent and rate at which a drug’s active ingredient is absorbed and becomes available at its target site of action. Bioavailability testing evaluates how a drug is absorbed, distributed, metabolized, and excreted (ADME). This helps determine:

• Optimal Dosage: Ensuring the drug reaches the required therapeutic levels without being toxic.

• Therapeutic Effectiveness: Understanding how well the drug performs in the body.

Combining scientific expertise with advanced bioanalytical technologies to provide reliable data for bioavailability and biosimilarity testing. Our studies assess drug absorption, bioequivalence, including structural and functional comparability. Techniques include PK/PD analysis and impurity profiling to ensure regulatory compliance and therapeutic efficacy.

Find out how we can help

Biosimilarity testing is specific to biosimilars, which are biologic drugs developed to be highly similar to an already approved reference biologic (originator). These tests confirm that a biosimilar matches the reference product in terms of:

• Structure: Including molecular size, folding, and post-translational modifications like glycosylation.

• Function: Demonstrating equivalent biological and therapeutic activity

What Is Biosimilarity Testing