Assay Report
Methods · Standard Curves · QC · Results
Quantify biotherapeutic drug levels in serum, plasma, and other biological matrices using electrochemiluminescence (ECL) — with 4–5 log dynamic range, 25 µL sample volume, and assay formats optimized for monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, and therapeutic peptides.
Pharmacokinetic assessment is a cornerstone of drug development — from preclinical candidate selection through clinical PK profiling. MSD offers distinct advantages for PK assays: the wide dynamic range reduces the need for sample dilution and reanalysis; the non-enzymatic SULFO-TAG detection eliminates substrate timing variability that plagues ELISA-based PK methods; and the 25 µL sample volume preserves precious preclinical and clinical samples for additional analyses.
Capture antibody (anti-drug or target protein) immobilized on the MSD plate captures the drug. A SULFO-TAG-labeled detection antibody generates the ECL signal. Best for: mAbs, Fc-fusion proteins, and therapeutic proteins where a matched antibody pair is available.
The drug is captured and detected by labeled forms of the same or complementary binding reagent. Best for: molecules where a matched antibody pair is unavailable, and for ADA assays where drug-specific bridging is required.
Signal is inversely proportional to drug concentration as labeled and unlabeled drug compete for binding. Best for: small peptides or molecules with a single binding epitope.
| Feature | MSD | ELISA | LC-MS/MS |
|---|---|---|---|
| Dynamic Range | 4–5 logs — single dilution for Cmax to trough | 2–3 logs — multiple dilutions required | 3–4 logs |
| Method Development | Days — antibody-based, standard formats | Days–weeks | Weeks — requires IS, chromatography optimization |
| Sample Volume | 25 µL | 100 µL | 50–200 µL |
| Throughput | ~70 sec/plate | Hours per plate | Minutes–hours per sample |
| Matrix Interference | Minimal — electrical excitation | Moderate — colorimetric | Low — chromatographic separation |
| Metabolite Distinction | No — antibody-dependent | No | Yes — mass-based |
| Best Fit | High-throughput PK screening; same platform as ADA | Low-volume studies; established labs | Definitive PK; metabolism studies |
| Item | Full Service | Notes |
|---|---|---|
| Method Development | Included | Antibody screening, format optimization, range-finding |
| Standard Curve | 8–10 point, each plate | Drug-specific calibrator in relevant matrix |
| QC Samples | 3–5 levels, duplicate | LLOQ/Low/Mid/High/ULOQ |
| Data Report | Full PK report | Concentrations, QC metrics, curve plots |
For Research Use Only. Not for diagnostic procedures. Assays use manufacturer-validated MSD reagents with documented QC protocols.
Provide drug information, target concentration range, and matrix type. We'll recommend the optimal format.
Antibody screening, format optimization, range-finding, and qualification in your matrix of interest.
Batch analysis with full QC documentation. PK concentration data with run acceptance metrics.
Every PK assay includes: standard curve parameters (R², back-fit accuracy), QC sample performance across all run levels, intra- and inter-assay precision metrics, and raw ECL signal data. Assays use manufacturer-validated MSD reagents with documented QC protocols. All services are for research and development use only.
MSD PK assays are suitable for: monoclonal antibodies (sandwich format using anti-idiotype or anti-Fc reagents); bispecific antibodies (bridging format); antibody-drug conjugates (ADCs) (total antibody + conjugated drug assays for DAR assessment); Fc-fusion proteins; therapeutic peptides (competitive format); biosimilars (comparative PK with reference product). Contact us with your molecule details for format feasibility assessment.
Both platforms have roles in PK bioanalysis. ECL: faster method development (days vs. weeks), higher throughput (~70 sec/plate), smaller sample volume (25 µL vs. 50–200 µL), no need for stable-isotope-labeled internal standards. LC-MS/MS: absolute specificity (mass-based detection), ability to distinguish drug from metabolites. Many programs use both — ECL for high-throughput PK screening, LC-MS/MS for definitive PK and metabolism studies.
Demo Assay Report
Request a representative report to review how assay methods, standard curves, quality-control metrics, and quantitative results are presented.
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