Anti-Human IL 12/23 (Briakinumab) – HRP

Research-grade Briakinumab biosimilars are used in pharmacokinetic (PK) bridging ELISAs as analytical standards (calibration standards) and reference controls to quantitatively measure Briakinumab concentrations in serum samples during biosimilar development.

In PK bridging ELISAs for biosimilars:

• A single research-grade biosimilar is typically selected as the calibration standard for the assay.
• Standard curve: Serial concentrations of the biosimilar are prepared in human serum or assay buffer and used to generate a standard curve, against which unknown samples (serum from subjects dosed with the drug) are quantified.
• Reference controls (quality controls, QC): Additional samples containing known concentrations of either the biosimilar or the reference product (originator Briakinumab) are included in each run to monitor the assay's performance and ensure data reliability.

Essential Context

• Using a single analytical standard—usually the biosimilar—helps reduce variability and provides consistent quantification for both biosimilar and reference product samples in PK bioequivalence studies.
• The biosimilar standard must be well-characterized for purity, concentration, and identity, and rigorously tested for analytical comparability with the originator product before assay validation.
• Regulatory and industry consensus supports one validated, robust method for all test products, anchoring similarity assessment to the biosimilar standard for both calibration and reference QC purposes.

Additional Relevant Information

• The Briakinumab biosimilar is available as a highly purified, sterile solution with >95% purity and low endotoxin, ensuring suitability for sensitive PK assays.
• ELISA kits for Briakinumab detection use coated wells and detection reagents that bind specifically to the drug, enabling quantitative measurement in serum and plasma.
• Biosimilar monoclonal antibodies for research use are broadly used as standards or controls not only for calibration but also as capture/detection reagents in ligand binding assays like PK ELISAs.

In summary, research-grade Briakinumab biosimilars serve as calibrators to generate standard curves and as reference controls to verify assay precision and accuracy, thus ensuring the reliable quantitation of Briakinumab in serum samples for PK studies.

Biopharma companies typically perform an extensive suite of analytical assays to confirm the structural and functional similarity of a proposed biosimilar to its originator (reference) biologic. These assays rigorously compare the biosimilar’s molecular properties across structural, physicochemical, and biological activity dimensions using state-of-the-art analytical platforms and validated methods.

Key Analytical Assays Commonly Used:

• Structural assays:

  • Primary structure analysis: Peptide mapping, mass spectrometry, sequencing, and amino acid analysis ensure that the primary protein sequence matches the reference.
  • Higher-order structure: CD spectroscopy, FTIR, NMR, and other biophysical techniques measure secondary, tertiary, and quaternary structure.
  • Post-translational modifications and glycosylation profiling: LC-MS, HPLC, and capillary electrophoresis detect differences in glycan structures, deamidation, oxidation, or other modifications.
  • Aggregation and purity: Size-exclusion chromatography, SDS-PAGE, and analytical ultracentrifugation assess aggregates, fragmentation, and impurities.

• Functional assays:

  • Biological potency: Cell-based bioassays evaluate the intended biological activity.
  • Binding assays: ELISA, SPR (surface plasmon resonance), and similar platforms measure binding affinities and kinetics to relevant targets or receptors, such as Fc receptor binding for antibodies.
  • Enzyme kinetics and mechanism-of-action studies: These confirm the biosimilar’s ability to replicate key functional activities associated with therapeutic effect.

• Impurity and variant analysis: Rigorous comparison of impurities, aggregates, fragments, and process-related variants using orthogonal (complementary) methods is essential.

• Critical Quality Attributes (CQAs): All these assays are designed to assess CQAs that are relevant to safety, efficacy, pharmacokinetics, and immunogenicity.

Assay Approach and Regulatory Expectations

Biopharma companies use a multi-dimensional battery of complementary (orthogonal) assays to build a robust analytical similarity profile. Demonstrating biosimilarity requires that any observed differences are not clinically meaningful—functionality must match, even if minor structural differences are detected. Regulatory bodies (FDA, EMA) require individualized, head-to-head comparative studies, often across multiple lots using highly sensitive methods. A particular emphasis is placed on those CQAs identified as most relevant to the mechanism of action and patient outcomes, and strength of evidence is increased through the use of overlapping techniques to probe the same attribute.

Use of Leinco Biosimilar in Analytical Studies

The search results do not directly mention use of Leinco biosimilar in these studies. However, based on industry practice, Leinco Biosciences is known for providing high-quality biosimilar reference or comparator proteins and antibodies, which may be used as either standards or controls in the above-described analytical comparability studies when direct access to the originator product is limited, or to supplement studies for cross-verification.

Typically, the Leinco biosimilar would be used as:

• A critical comparative control in binding, potency, and functional assays, to verify similarity.
• A benchmark molecule in structural characterization, especially in orthogonal or platform-based studies when the original innovator drug is not commercially available or is prohibitively expensive.

It is important to confirm with individual Leinco product technical sheets how each biosimilar is validated for use in regulatory comparability studies, but the broader approach is consistent across biosimilar developers.

In summary:Biopharma biosimilar programs use advanced physicochemical and functional testing—including mass spectrometry, chromatography, spectroscopy, binding and cell-based assays—to demonstrate high similarity to the reference biologic. Leinco biosimilars serve as comparison standards in these studies, ensuring accurate benchmarking when direct use of the originator is impractical.