Understanding TNF-α in Diagnostics
Tumor Necrosis Factor-alpha (TNF-α) is a central cytokine in inflammation and immune signaling. Dysregulated TNF-α levels are implicated in autoimmune diseases such as rheumatoid arthritis, psoriasis, and IBD (Novus Biologicals, Reprocell). In in-vitro diagnostics (IVDs), accurate detection of TNF-α serves both as a biomarker in disease states and as a target for anti-TNF therapeutics.
How Recombinant TNF-α affects IVD?
1. Consistency across Batches
Recombinant production ensures batch-to-batch uniformity (>98% purity, minimal endotoxin) unlike native sources. This improves assay reproducibility and standard curve stability (Alomone Labs, abcam.com).
2. High Biological Activity & Sensitivity
Studies report EC₅₀ values as low as 12.5 pg/mL in L929 cytotoxicity assays (Alomone Labs, www.rndsystems.com, Bio-Rad). That level of activity enables ultra-sensitive IVDs that accurately quantify low-level inflammatory markers.
3. Scalable & Regulatory-Ready Supply
Produced via E. coli or mammalian systems, recombinant TNF-α supports large-scale manufacturing and consistency needed for CE-IVD or FDA regulatory filings
(PubMed, www.rndsystems.com).
deNOVO’s capability
At deNOVO Biolabs, our recombinant TNF-α proteins are:
- Expressed in E. coli or CHO systems for GMP-consistent trimer formation (~17–53 kDa) (www.rndsystems.com, InvivoGen).
- Purified to ≥ 96–98% purity with full biological activity and minimal endotoxin.
- Validated in functional assays (e.g., L929 cell cytotoxicity, ELISA standard curves).
- Supplied with COA/TDS to support IVD assay design, kit development, and regulatory submissions.
Value to Diagnostic Manufacturers
- Faster assay development:
Skip optimizing variable native protein lots. - Better sensitivity and dynamic range:
High activity enables detection even at low biomarker levels. - Regulatory alignment:
Consistent documents, stability, endotoxin control. - Flexibility:
Available in multiple formats & concentrations—ideal as calibration standards or positive controls.
Use Cases
- TNF-α detection in sepsis and autoimmune diagnostic panels.
- Kit validation for anti-TNF therapeutic monitoring
(e.g., infliximab, adalimumab) (Novus Biologicals). - Research in inflammation biology and cytokine signaling using standardized standards.
Why choose us?
With deep experience supporting diagnostic R&D, deNOVO’s recombinant TNF-α offerings stand out for:
- Reagent reliability built on rigorous QC and biological validation.
- Scalable supply facilitating both early-stage assay testing and full-scale production.
- Technical collaboration, including application support and dossier-ready documentation.
Ready to power your IVD assays with high-precision recombinant TNF-α?
Contact us today to request a technical brochure, sample kit, or application discussion. Let’s innovate diagnostics together.
References
- Hoffmann et al. (2010), “Recombinant production of bioactive human TNF-α in E. coli” describes high-yield SUMO-fusion manufacturing and >96% purity yields (PubMed).
- Bioactivity and EC₅₀ cytotoxicity data sourced from R&D Systems, Alomone Labs, Abcam products demonstrating reagent sensitivity in L929 cells (>25 pg/mL threshold) (www.rndsystems.com, Alomone Labs, abcam.com).