Recombinant Cascade Reagent (rCR) (Kinetic-Chromogenic Assay)

Name: Recombinant Cascade Reagent (rCR) (Kinetic-Chromogenic Assay)
Brand: SHENTEKBIO
Availability: InStock

Product Number: 1501112

The bacterial endotoxin test (BET) is a critical part of pharmaceutical quality control (QC), as endotoxins can trigger severe immune responses in humans and animals even at trace levels. Traditional testing relies on Limulus amebocyte lysate (LAL), which impacts natural resources while also presenting challenges such as cross-reactivity and lot-to-lot variability.

The United States Pharmacopeia (USP) introduced new chapters in May 2025 permitting recombinant reagents (rCR, rFC) for endotoxin detection. Building on this regulatory milestone, SHENTEK offers a recombinant cascade reagent (rCR), providing an advanced and eco-sustainable alternative to conventional LAL tests, ensuring higher consistency, quality control, and safety assurance for pharmaceuticals.

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Overview - EndoSynXTM^® Recombinant Cascade Reagent (rCR) (Kinetic-Chromogenic Assay)

The EndoSynX^TM Recombinant Cascade Reagent (rCR) is a recombinant endotoxin detection system that mimics the enzymatic cascade of natural Limulus Polyphemus Lysate and it contains Recombinant Factor C, Recombinant Factor B, and Recombinant Proclotting Enzyme. Upon exposure to Gram-negative bacterial endotoxin (lipopolysaccharide, LPS), recombinant Factor C is activated, which will then activate the cascade enzyme system of serine, generating a kinetic chromogenic signal that correlates with the concentration of endotoxin. The EndoSynX^TM rCR does not contain Factor G, eliminating interference from β-D-glucan and Limulus Amebocyte Lysate-reactive materials in test samples. The kit is suitable for quantitative determination of endotoxin in pharmaceutical products.

The kit is for RESEARCH USE ONLY and not intended for clinical use.

Application

1. Injectable drugs for human and veterinary use (e.g., chemical drugs, radiopharmaceuticals, antibiotics, biological products)

2. Medical devices - raw and auxiliary materials, intermediates, and finished products (e.g., dialysates, implantable devices)

Introduction - EndoSynXTM Recombinant Cascade Reagent (rCR) (Kinetic-Chromogenic Assay)

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

Key Features - EndoSynX^TM Recombinant Cascade Reagent (rCR) (Kinetic-Chromogenic Assay)

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
Sample	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 (%)
Test Sample	MVD (λ=0.005EU/mL)	Recombinant Cascade Reagent (rCR)	Recombinant Factor C (rFC)	Recombinant Cascade Reagent (rCR)	Recombinant Factor C (rFC)
Cell Culture Supplement (Pink)	100	2	16	122.6	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