Data speaks louder than claims in a biosimilar landscape shaped by precision and performance. Denovo Biolabs has taken a significant step toward improving biosimilar drug development and regulatory confidence by publishing a peer-reviewed study on a validated ELISA method to quantify Adalimumab, one of the most widely prescribed monoclonal antibodies.
This proprietary assay isn’t just another bioanalytical tool—it’s a practical solution designed for drug manufacturers and clinical researchers to confidently monitor drug levels, support comparability studies, and strengthen pharmacovigilance programs.
📖 Read the Publication in Biochemistry and Biophysics Reports (Elsevier, 2025)
The need to quantify Adalimumab
Adalimumab (marketed as Humira®) is a cornerstone biologic for autoimmune disorders such as rheumatoid arthritis, Crohn’s disease, and psoriasis. As global patents continue to expire, biosimilars of adalimumab are entering markets with the promise of affordability, but not without strict regulatory scrutiny.
In this high-stakes scenario, validated pharmacokinetic (PK) assays serve multiple critical functions:
✅ Ensuring Bio-comparability
Establish that the biosimilar mimics the reference product in terms of exposure and therapeutic window.
✅ Quality Control in Manufacturing
Maintain consistency across batches using measurable, reproducible parameters.
✅ Clinical Monitoring
Optimize patient outcomes by adjusting dosing based on serum drug levels and immune response.
Without reliable PK tools, biosimilar development becomes a game of guesswork. Denovo’s ELISA eliminates that uncertainty.
Inside the Assay
The assay described in Denovo’s recent publication is built around recombinant human TNF-α (rhTNF-α), the natural binding target of adalimumab.
Here’s what makes it special:
Capture Specificity Using Recombinant Antigen 🔬
- Utilizes high-purity rhTNF-α to capture free adalimumab from serum samples.
- Mimics the physiological binding environment for better accuracy.
Sensitivity & Quantification Range 📈
- Detection limit: 5.2 ng/mL
- Linear range: 5.2–200 ng/mL
- Ideal for tracking both low-dose and high-exposure PK scenarios in clinical trials.
Specificity Validated Against Off-Target Interference 🧪
- No significant cross-reactivity with non-TNF inhibitors such as rituximab.
- High confidence in results across biologics-rich patient serum.
Regulatory-Ready Validation ✅
- Conforms with EMA bioanalytical method validation guidelines.
- Evaluated for accuracy, reproducibility, and stability across time points.
Real-World Utility
This assay wasn’t built in isolation—it was developed with real-world use cases in mind, making it viable for both manufacturing QC and clinical research:
In Manufacturing: Quality Control Assay
- Can be deployed as a lot release test to confirm the consistent potency of adalimumab biosimilars.
- Supports comparability data in the tech transfer and scale-up phases.
In Clinical Trials: Monitoring Tool
- Measures trough and peak serum levels in biosimilar-treated patients.
- Detects deviations in therapeutic response early—helpful in managing immunogenicity or patient variability.
Collaborative Science, Local Innovation
The study was co-authored with researchers from JSS Academy of Higher Education & Research, reflecting Denovo Biolabs’ continued commitment to academic–industry partnerships and knowledge-driven innovation.
It also reinforces Denovo’s mission to deliver Made-in-India biotech solutions that are globally competitive—bringing together affordability, quality, and scientific rigor.
Want to implement this assay in your workflow?
Reach out at: info@denovobiolabs.com
Denovo’s Commitment to Biosimilar Bioanalytics
If you are building your first biosimilar molecule or fine-tuning clinical performance, Denovo’s ELISA platform can become your foundation for data-driven decision-making. Our offerings include:
- Custom assay development for biologics & biosimilars
- Validated PK & immunogenicity ELISA kits
- Bulk recombinant proteins for assay integration
- Consultation on analytical strategy and regulatory readiness
Final Thoughts
With rising competition and tighter regulatory frameworks, the biosimilar industry can no longer afford analytical ambiguity. Denovo’s validated ELISA for Adalimumab:
- Aligns with global validation requirements
- Delivers high analytical precision
- Enables QC and clinical utility
- Supports both upstream and downstream stakeholders in biosimilar programs
And perhaps most importantly, it was developed, tested, and validated in India, showing that world-class bioanalytics does not have to come with a multinational price tag.
Interested in Licensing or Customizing This Assay?
Let’s talk:
📧 info@denovobiolabs.com
🌐 www.denovobiolabs.com