EndoSynX^TM Recombinant Cascade Kinetic-Chromogenic Assay (For Endotoxin Test)

Name: EndoSynX TM Recombinant Cascade Kinetic-Chromogenic Assay (For Endotoxin Test)
Brand: SHENTEKBIO
Availability: InStock

For Research Use Only (RUO)

Product Number: 1501114

Endotoxin contamination during bioprocessing primarily originates from microbial contamination (especially Gram-negative bacteria), endotoxin release following cell lysis, contaminated equipment and raw materials, as well as inadequate downstream processing.

To ensure the safety of biological products for human use, endotoxin testing is a mandatory requirement for pharmaceutical product release. However, the currently dominant endotoxin detection method, the Limulus Amebocyte Lysate (LAL) assay, faces challenges related to limited natural resources, increasing environmental protection concerns, and performance variability associated with naturally derived materials.

SHENTEK provides an alternative endotoxin testing solution through the EndoSynX™ Recombinant Cascade Kinetic-Chromogenic Assay (rCKA) Kit, which delivers results comparable to traditional LAL assays while offering a reliable and sustainable alternative to conventional animal-based testing methods.

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EndoSynX<sup>TM</sup> Recombinant Cascade Kinetic-Chromogenic Assay (For Endotoxin Test)

Overview - EndoSynX^TM Recombinant Cascade Kinetic-Chromogenic Assay (For Endotoxin Test)

The EndoSynXTM Recombinant Cascade Kinetic-Chromogenic Assay (rCKA) is an advanced recombinant endotoxin detection system that mimics the enzymatic cascade of the natural Limulus Polyphemus Lysate using Recombinant Factor C, Recombinant Factor B, and Recombinant Proclotting Enzyme. Upon exposure to Gram-negative bacterial endotoxin (lipopolysaccharide, LPS), recombinant Factor C is activated, subsequently activate the serine cascade enzyme system that generates a kinetic chromogenic signal that correlates with the concentration of endotoxin. This fully recombinant protein cascade eliminated β-D-glucan induced Factor G interference in the traditional Limulus Amebocyte Lysate (LAL) assay, and made it suitable for the quantitative determination of endotoxin in pharmaceutical products.

The product described herein is for research use only and is not intended for diagnostic or therapeutic 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 - EndoSynX^TM Recombinant Cascade Kinetic-Chromogenic Assay (For Endotoxin Test)

Components	Shipping Condition	Unit Size	Detection Method
Recombinant Cascade reagent A	2-8℃	96 Tests	Recombinant Cascade
Recombinant Cascade reagent B
Recombinant Cascade Buffer
Control Standard of Endotoxin
96-well Microplate
Water for BET

Key Features - EndoSynX^TM Recombinant Cascade Kinetic-Chromogenic Assay (For Endotoxin Test)

Linearity & Range	0.005 EU/mL to 5 EU/mL
Reduced False Positives	Free of Factor G, 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