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Description
The bacterial endotoxin test (BET) is an essential component of pharmaceutical quality control (QC), as endotoxins can trigger strong immune responses in humans and animals even at trace levels. Conventional testing methods based on Limulus Amebocyte Lysate (LAL) depend on harvesting horseshoe crabs, raising sustainability concerns, and are subject to challenges such as cross-reactivity and lot-to-lot variability.
In May 2025, the United States Pharmacopeia (USP) introduced new chapters permitting recombinant reagents (rCR, rFC) for endotoxin detection. Building on this regulatory milestone, SHENTEK® Recombinant Cascade Reagent (rCR) offers a reliable, eco-sustainable alternative to LAL-based assays. This recombinant reagent ensures improved batch-to-batch consistency, robust quality control, and enhanced safety assurance for pharmaceutical testing applications.
Overview
The SHENTEK® Recombinant Cascade Reagent (rCR) is a recombinant endotoxin detection system based on a cascade enzyme reaction synthesized by recombinant expression. It mimics the reaction mechanism of natural Tachypleus amebocyte lysate by specifically recognizing endotoxins. The kit contains recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme, enabling sensitive and quantitative detection of endotoxins from Gram-negative bacteria in test samples.
Unlike natural lysate, this recombinant system does not contain the G factor, effectively eliminating interference from β-D-glucan and other LAL-reactive substances. This ensures higher specificity and reliability compared to conventional LAL assays.
This product is suitable for quantitative endotoxin detection in human and veterinary injectable drugs, biological products, and medical devices.
Applications
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Injectable drugs for human and veterinary use – including chemical drugs, radiopharmaceuticals, antibiotics, and biological products.
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Medical devices – testing of raw materials, auxiliary materials, intermediates, and finished products (e.g., dialysates, implantable devices).
Introduction
| Components | Shipping Condition | Unit Size | Detection Method |
| Recombinant cascade reagent A | 2-8℃ | 96 Tests | Recombinant Cascade |
| Recombinant cascade reagent B | |||
| Recombinant cascade buffer | |||
| 96-well Microplate | |||
| Water for BET |
Features
| Linearity & Range | 0.005 EU/mL to 5 EU/mL |
| Reduced False Positives | Free of G-Factor, effectively eliminating interference from β-D-glucan and LAL-reactive substances. |
| Rapid Detection | Results available within 60 minutes. |
| Regulatory Compliance | USP <85>, FDA BET guidance, ICH Q6B |
| 3R-Aligned | Supports Replace, Reduce, Refine in testing |
| Proven Performance | Equivalent to gel-clot, KTA, and chromogenic methods |
| High Consistency | Recombinant production ensures lot-to-lot reproducibility |
| Animal-Free | Eco-friendly alternative to traditional LAL |
Equivalence in Endotoxin Detection: Recombinant Cascade Reagent vs. LAL Reagent
| Sample | Recombinant Cascade Reagent | LAL Reagent | ||||
| Average Detection Value (EU/mL) | Spike Recovery (%) | CV after Spiking (%) | Average Detection Value (EU/mL) | Spike Recovery (%) | CV after Spiking (%) | |
| Cell Culture Supplement | <0.005 | 122.6 | 4.493 | <0.005 | 101 | 2.789 |
| 300 g/L Glucose | <0.005 | 70 | 4.199 | <0.005 | 82.2 | 1.774 |
| FBS | <0.005 | 110.4 | 4.284 | <0.005 | 96 | 4.284 |
| Medium | <0.005 | 114 | 0.549 | <0.005 | 123.2 | 1.07 |
| Cell Culture Supernatant | <0.005 | 95.4 | 2.175 | <0.005 | 152.4 | 12.348 |
| Live Attenuated Hepatitis A Vaccine | <0.005 | 96.6 | 0.524 | <0.005 | 123.6 | 2.732 |
| mAb A | 0.026 | 175.4 | 2.181 | 0.034 | 156.6 | 0.908 |
| mAb B | <0.005 | 139 | 0.579 | <0.005 | 130.8 | 2.02 |
| 0.1% BSA | <0.005 | 92.4 | 14.716 | 0.009 | 89.8 | 0.923 |
Superior Anti-Interference Capability
| Test Sample | MVD (λ=0.005EU/mL) |
Non-Interfering Dilution (NID) | Spike Recovery (%) | ||
| Recombinant Cascade Reagent (rCR) | Recombinant Factor C (rFC) | Recombinant Cascade Reagent (rCR) | Recombinant Factor C (rFC) | ||
| Cell Culture Supplement (Pink) | 100 | 2 | 16 | 1226 | 79 |
| Emulsifier (Milky White) | 1000 | 40 | 640 | 110.4 | 151.8 |
| Cell Culture Supernatant (with Phenol Red) | 200 | 1 | 200 | 95.4 | 126.8 |
| mAb A (High Protein) | 200 | 1 | 2 | 175.4 | 135.4 |
| Saline for Injection (High Salt) | 50 | 16 | 2 | 89.6 | 116.8 |
For Research Use Only. Not intended for clinical use.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
