● In-House IVD Critical Raw Material Manufacturer

Critical Monoclonal Antibodies & Reagents for Neurodegenerative Biomarker Assays

Engineered for sub-picogram analytical sensitivity across CLIA, Simoa, and point-of-care platforms. As a dedicated supplier of clinical-grade IVD raw materials, we deliver validated matched antibody pairs and recombinant calibrators with multi-gram batch consistency and strict lot-to-lot reproducibility.

⚡ Multi-Gram Capacity

Scalable in-house cell culture & purification for bulk industrial demand.

🎯 Sub-pg/mL Sensitivity

Validated on CLIA & digital single-molecule diagnostic platforms.

🔬 Lot-to-Lot CV < 5%

Strict batch release criteria with complete analytical CoA documentation.

🌍 Global Cold-Chain

Temperature-controlled express delivery to worldwide R&D facilities.

AD Early Detection

p-Tau217 Monoclonal Antibody Pair

Cat. No.: RDM013 / RDM012
  • Target:Phospho-Tau (Thr217)
  • Host/Type:Mouse / mAb
  • Applications:ELISA, CLIA, WB
  • Calibrator:Human p-Tau217
  • Reactivity:Human
View Details & Specs →
Amyloid Cascade

Aβ1-42 Monoclonal Antibody Pair

Cat. No.: RDM009 / RDM011
  • Target:Human Aβ1-42
  • Host/Type:Mouse / mAb
  • Applications:ELISA, CLIA, WB
  • Calibrator:Human Aβ1-42
  • Companion:Aβ1-40 Available
View Details & Specs →
TBI Biomarker

GFAP Monoclonal Antibody Pair

Cat. No.: RDM016 / RDM017
  • Target:Human GFAP
  • Host/Type:Mouse / mAb
  • Applications:CLIA, ELISA, WB
  • Calibrator:Recombinant GFAP
  • Quality:Purity >95%
View Details & Specs →
Axonal Damage

NFL Matched Antibody Pair

Cat. No.: RDM014 / RDM015
  • Target:Neurofilament Light
  • Host/Type:Mouse / mAb
  • Applications:ELISA, CLIA, WB
  • Calibrator:Recombinant NFL
  • Quality:Purity >95%
View Details & Specs →
Tailored Manufacturing

Tailored IVD Reagent Solutions & OEM Manufacturing

Eliminating international biological import barriers. Accelerate your assay pipeline with customized conjugations, custom buffer formulations, and sequence-based recombinant synthesis under mutual NDA.

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Ready-to-Use Conjugation & Labeling

Bypass in-house coupling losses and batch inconsistencies. Receive assay-ready antibody conjugates tailored specifically for your target detection technology.

  • ✓ Acridinium Ester (AE) labeled for CLIA
  • ✓ High-affinity Biotinylation (custom spacer arms)
  • ✓ HRP, ALP, & fluorescent fluorophores (FITC)
  • ✓ Functionalized magnetic microparticle coating
Inquire About Conjugation →
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Custom Formulation & Bulk Filling

Engineered for clinical kit manufacturing lines. We accommodate specific buffer matrices, zero-preservative requests, and gram-scale sterile batch packaging.

  • ✓ Preservative-free (Sodium Azide-free) options
  • ✓ Tailored buffer exchange (Trehalose, Glycerol, PBS)
  • ✓ High-concentration concentrates (up to 10 mg/mL)
  • ✓ OEM private labeling & customized fill volumes
Request Bulk Packaging →
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Sequence-to-Protein Synthesis

Zero physical sample shipping hurdles. Provide your FASTA sequence electronically for high-fidelity recombinant antigen and calibrator production.

  • ✓ Mammalian (HEK293 / CHO) & E. coli expression
  • ✓ Phosphorylated & conformational mutant targets
  • ✓ Recombinant authentic calibrators & controls
  • ✓ Stringent purity assessment (>95% SDS-PAGE/SEC)
Submit Sequence Specs →
No Biological Customs Import Needed
Mutual NDA IP Protection
Full Lot CoA & Analytical Dossier
Global Cold-Chain Delivery
Discuss Custom Project →
Quality Excellence & Industrial Standards

Technology Platforms & Quality Advantages

Eliminating batch variance in clinical diagnostic manufacturing. Engineered with strict biophysical release criteria to guarantee robust analytical reproducibility across diverse immunoassay architectures.

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CV < 5% Verified

Ultra-Low Lot-to-Lot Variation

Scale-up protocols eliminate inter-batch drift. We establish single-batch bioreactor fermentation up to multi-gram scales, preventing frequent platform re-calibration for diagnostic kit developers.

  • ■ Strict lot-to-lot CV < 5% across analytical calibration curves
  • ■ Cryopreserved Master & Working Cell Banks (MCB/WCB)
  • ■ Gram-scale single harvest lots with identical binding kinetics
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Clinical Grade

Multi-Platform Analytical Validation

Not just RUO binding tests. Raw materials are rigorously screened and paired directly on magnetic microparticle CLIA, ELISA, and digital single-molecule (Simoa) platforms against real human serum and plasma.

  • ■ Spike-and-recovery rates maintained within 90% – 110%
  • ■ Minimal interference from endogenous bilirubin, lipids, & HAMA
  • ■ Benchmarked against international reference standards and PET status
🛡️
SEC-HPLC > 98%

Stringent Biophysical QC Release

Every delivered batch is characterized through an orthogonal analytical battery to confirm monomer purity, binding kinetics, and prolonged shelf-life stability before release.

  • ■ Monomer purity > 98% via analytical Size-Exclusion HPLC (SEC-HPLC)
  • ■ Real-time binding kinetics ($K_D$, $k_{on}$, $k_{off}$) by BLI / SPR analysis
  • ■ Accelerated thermal stability validation (14 days at 37°C without loss)
Need to evaluate our Certificate of Analysis (CoA) & Analytical Dossier?

We provide comprehensive analytical packages including HPLC profiles, BLI sensorgrams, and matrix recovery data upon inquiry.

Request Sample CoA Package →
Accelerate Your Pipeline

Ready to Validate or Scale Your Diagnostic Assay?

Request evaluation sample packs, review detailed analytical validation reports, or discuss bulk supply agreements directly with our technical support team.

✓ Gram-to-Kilogram Bulk Capacity
✓ Complete CoA & Analytical Dossiers
✓ In-Stock Evaluation Samples Shipped in 24–48h