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Overview of ADC components and related CQAs, highlighting how antibody, linker, and payload heterogeneity affect potency, stability and safety.
Biosimilar drugs development in 2025 and 2026 explained. How FDA and EMA are shifting toward analytical similarity and reduced clinical studies.
Antibody-drug conjugates (ADCs) bioanalysis requires robust methods to track antibodies, payloads, and drug-to-antibody ratio changes in vivo. Here is an overview of the two main strategies.
Adjusting Minimal Required Dilution (MRD) from 1:4 to 1:2 in a competitive ligand binding assay improved NAb assay sensitivity 4-fold and drug tolerance 5-fold. See the data and methodology.
Our experts developed a PD-1 receptor occupancy (RO) assay to monitor drug–target interactions and support pharmacodynamic evaluation in clinical studies.
Our scientists developed a strategy to reduce false positives and improve the reliability of ADA assays
Our experts established a bioanalytical strategy to eliminate false positive signals caused by soluble drug targets in ADA assays, improving the accuracy of immunogenicity assessment for therapeutic proteins.
Our experts developed a highly sensitive and specific workflow to quantify total antibodies, conjugated payload, and free payload in antibody–drug conjugates (ADCs).
Discover how our experts developed FACS-based immunophenotyping method to monitor T and NK cell populations in solid tumor treatment studies.
In this case study our experts developed an ADA assay for a prodrug where traditional acid dissociation alone could not meet tolerance requirements.
In this case study our experts developed an LC-MS/MS method for oligonucleotide pharmacokinetic (PK) analysis in a Phase 1 clinical studies.
CMC analytical readiness determines whether biologic programs can absorb change without losing regulatory credibility across development and lifecycle stages.
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