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Your Position: ホーム > Ultra-Low Endotoxin Proteins: Reliable & Ideal for In Vivo Use

Introduction

In drug development, proteins serve as indispensable upstream reagents that play pivotal roles across multiple in vivo applications. As target validation tools, recombinant proteins such as cytokines and growth factors are employed to investigate target mechanisms in disease models. In antibody therapeutics development, these proteins function both as immunogens for antibody generation and as critical reagents for functional validation studies. Meanwhile, various tool proteins including reporter proteins and gene-editing enzymes are widely utilized for in vivo imaging and genetic manipulation research. Beyond these applications, protein reagents also contribute to viral vector system development (e.g., viral packaging proteins), establishment of biomarker reference standards, and evaluation of novel delivery system biodistribution profiles. It's particularly noteworthy that in addition to purity and bioactivity, stringent low-endotoxin characteristics of these protein reagents represent an essential quality attribute - a critical determinant for ensuring reliable experimental data throughout the drug development process.

Even trace amounts of endotoxin (LPS) can compromise experimental outcomes through multiple mechanisms: In target validation studies, LPS-triggered nonspecific immune responses may obscure the true biological activity of target proteins; during antibody potency assessment, endotoxin contamination could lead to false-positive or false-negative readouts; while in delivery system evaluations, LPS-induced inflammatory reactions may dramatically alter the biodistribution profiles of test proteins. Particularly concerning are repeated-dose or chronic studies, where cumulative endotoxin effects may provoke febrile reactions or tissue damage in animal models, potentially invalidating entire research programs. This makes endotoxin-controlled protein reagents (<0.5 EU/mg) not merely a quality preference, but a fundamental necessity - ensuring data reliability, enhancing experimental reproducibility, and ultimately accelerating drug development timelines.

ACROBiosystems is dedicated to realizing the vision of “Where Proteins and Innovations Advance Biomedicine.” We have developed a stringent protein production system specifically designed to meet the practical needs of research applications. Our manufacturing process utilizes endotoxin-free expression systems such as HEK293 cells, combined with multi-step chromatographic purification techniques including ion exchange and affinity chromatography, along with specialized endotoxin removal protocols. Throughout production, we strictly avoid using any animal-derived components or harmful chemical additives to ensure product safety and reliability.

All ultra-low endotoxin protein products meet our rigorous <0.5 EU/mg standard - surpassing conventional research-grade requirements - with comprehensive LAL method and recombinant factor C (rFC) method validation. These ultra-low endotoxin proteins deliver exceptional performance for critical in vivo applications from target validation to therapeutic antibody development and delivery system assessment, accelerating the entire drug discovery pipeline.

Note: The <0.5 EU/mg specification balances scientific rigor (reliable in vivo data) and industrial practicality (reproducible manufacturing)

Core Features

Superior Quality Standards

Ultra-low endotoxin (<0.5 EU/mg) – surpassing routine research-grade (1-5 EU/mg)1
Near-therapeutic grade (approaching 0.1 EU/mg drug standards) 2

Professional Production Process

Endotoxin-free expression systems (e.g., HEK293)
Multi-step chromatographic purification (Affinity + Ion Exchange)
Specialized endotoxin removal technology

Safety Assurance

Animal-origin free
No harmful chemical additives
Rigorous LAL and rFC testing

Broad Applicability

Comprehensive in vivo compatibility
Reliable experimental data
Non-specific immunity prevention

Product List

MoleculeCat. No.Product Description

Innovation Never Stops – More Ultra-Low Endotoxin Products Coming Soon! Stay Tuned.

References

1. Moerings, B. G. J., et al. (2025). Induction of endotoxin tolerance in murine monocyte and macrophage cell populations – optimal LPS dose and compartment-specific reversal by β-glucan. Food & Function, 16, 1576–1587. https://doi.org/10.1039/d4fo05223d

1. U.S. Food and Drug Administration (FDA). Bacterial Endotoxins/Pyrogens Inspection Guide. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/bacterial-endotoxinspyrogens

“Structure & Application Integrated” Protein Development Platform “Structure & Application Integrated” Protein Development Platform

ACRO Quality

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