Biosimilars

Confident biosimilar development starts here

Biosimilars are biologic medical products that are highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Unlike small-molecule generics, biologics are large, structurally complex proteins produced in living systems. As a result, even minor variations in cell lines, manufacturing processes, or formulation can influence critical quality attributes such as glycosylation patterns, higher-order structure, aggregation, and binding activity.

Regulatory agencies including the U.S. Food and Drug Administration and the European Medicines Agency require comprehensive analytical comparability exercises to demonstrate biosimilarity. This demands robust, sensitive, and reproducible bioanalytical methods capable of detecting subtle differences between a biosimilar candidate and its reference product across multiple attributes - particularly functional binding and immunogenicity risk.

High sensitivity and wide dynamic range
Gyrolab’s nanoliter-scale microfluidic technology enables highly sensitive detection of binding interactions across a broad concentration range, supporting accurate quantification of low-abundance analytes and subtle potency differences.

Superior matrix tolerance
The flow-through format reduces background in complex matrices such as serum. This can negate potential specificity/selectivity issues that may be observed in patient samples e.g. Rheumatoid Arthritis.

Exceptional precision and reproducibility
Automated workflows minimize manual intervention and variability, delivering consistent results critical for comparability studies. Reliable reproducibility strengthens confidence when demonstrating equivalence between biosimilar and reference products.

Low sample and reagent consumption
The microfluidic format significantly reduces sample and reagent volumes - an important advantage when reference material is limited or costly.

Multiparametric binding and potency assessment
Gyrolab systems are well-suited for evaluating target binding, receptor interactions, and anti-drug antibody (ADA) responses. This supports comprehensive characterization of functional similarity and immunogenicity risk, both central to regulatory submissions.

Streamlined method transfer and scalability
Standardized assay protocols and automation facilitate method development, validation, and transfer across laboratories, ensuring consistency from early development through regulatory filing and post-approval lifecycle management.

Time to results

Results in just over an hour, compared to several hours or overnight with ELISA.

Hands-on time

Automated processing reduces manual pipetting and intervention.

Dynamic range

Fewer dilutions are needed to bring samples into range.

Matrix tolerance

The flow-through format reduces background in complex matrices such as serum.

Sample volume

Nanoliter-scale assays require significantly smaller sample volumes than plate-based methods.

Throughput and runs required

Higher pass rates and faster runtimes reduce repeat burden keeping your project timelines on track.

Validation and data confidence

Gyrolab is used in bioanalytical preclinical and clinical environments where data integrity, traceability, and reproducibility matter. Automated workflows reduce operator-dependent variation, while software support provides audit trails, controlled user access, and structured data handling to support compliance with GLP/GMP expectations.

Assays can be transferred between systems and sites with reproducible results, supporting long-term studies and regulatory submissions without added complexity.

Confident biosimilar development starts here

Why is ideal for biosimilar analysis

Biosimilars workflows supported by Gyrolab

Gyrolab^® 2G Generic PK Kit

Gyrolab Generic PK Kit

Gyrolab^® Generic Cyno ADA Kit Reagents

Gyrolab^® Generic Rodent ADA Kit Reagents