Low Endotoxin Recombinant Proteins—— Raising the Reliability Standard in Drug Discovery and Development

Endotoxin Control: The Hidden Challenge in Biopharma R&D

Recombinant proteins are indispensable upstream reagents in drug discovery and development, playing a central role in target validation, antibody generation, enzyme tools, and delivery system evaluation. Their quality directly shapes data reliability and the overall efficiency of research progress. However, endotoxins—lipopolysaccharides (LPS) from the cell walls of Gram-negative bacteria—pose a serious, often overlooked threat. Even trace amounts can trigger nonspecific immune responses, leading to multiple risks:

• Distorted results: False positives/negatives in cell-based and immunological assays, masking or misrepresenting true effects.

• Pharmacokinetic interference: Altered protein distribution and metabolism in vivo, compromising PK studies.

• Animal welfare concerns: Fever, shock, or even death in experimental animals, raising ethical issues and jeopardizing study continuity.

Stringent endotoxin control in recombinant proteins is therefore a non-negotiable prerequisite for data accuracy, reproducibility, R&D efficiency, and ethical compliance.


Ultra-Low Endotoxin Proteins (<0.5 EU/mg): Minimizing Immune Stress, Ensuring Reliable Results

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 ultra-low endotoxin recombinant proteins (<0.5 EU/mg) reduce immune stress and ensure reliable, high-quality antibody generation.

Key Advantages
Ultra-Low Endotoxin Level (<0.5 EU/mg): Meeting the USP <85> standard used throughout biopharma.
Animal-friendly: Minimizes immune stress in animal studies, particularly large-animal immunization and in vivo injection research.


Low Endotoxin Proteins (<10 EU/mg): Flexible Solutions for Broader Possibility Needs

Alongside ultra-low endotoxin portfolio, we also offer low endotoxin proteins (<0.01 EU/µg, equivalent to <10 EU/mg) to meet diverse research requirements.

Key Advantages
Economical: Ideal for large-scale screening and early validation studies.
Reliable: Consistent quality with controlled endotoxin levels.
Fast availability: Most products in stock, supporting accelerated research timelines.
Versatile: Compatible with a wide range of experimental systems and platforms.

Excellence in Quality Control and Assurance

Professional Production Process Superior Quality Standards
Endotoxin-free expression systems (e.g., HEK293) to minimize contamination at the source.
Advanced purification workflows, multi-step chromatography (ion-exchange, affinity, etc.) combined with dedicated endotoxin removal technologies.
Free of animal-derived components and unnecessary additives, ensuring safety, consistency, and regulatory compliance.
Rigorous endotoxin testing, validated by LAL or recombinant Factor C assays, ensuring industry-leading accuracy.
High purity and structural integrity, confirmed by SDS-PAGE, SEC-HPLC, and SEC-MALS.
Proven bioactivity and affinity, validated by ELISA, SPR, and BLI, with excellent batch-to-batch consistency.

Core Features

Application Scenarios

Product List

Ultra-Low Endotoxin Proteins (<0.5 EU/mg)
Low Endotoxin Proteins (<10 EU/mg)

Verification Data

High purity and structural integrity verified by SDS-PAGE & SEC-MALS
High purity and structural integrity verified by SDS-PAGE & SEC-MALS

Human PD-L1 Protein, His Tag (Cat. No. PD1-H5223) on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).

High purity and structural integrity verified by SDS-PAGE & SEC-MALS

The purity of Human 4-1BB Protein, His Tag (Cat. No. 41B-H52H3) is more than 90% and the molecular weight of this protein is around 28-38 kDa verified by SEC-MALS.

High bioactivity verified by ELISA
High bioactivity verified by ELISA

Immobilized Human CD40 Protein, His Tag (Cat. No. CD0-H52H4) at 1 μg/mL (100 μL/well) can bind Human CD40 Ligand Protein, Fc Tag, premium grade (Cat. No. CDL-H5269) with a linear range of 0.2-3 ng/mL (QC tested).

High bioactivity verified by ELISA

Immobilized Cynomolgus IL-11 Protein, His Tag (Cat. No. IL1-C5244) at 5 μg/mL (100 μL/well) can bind Human IL-11 R alpha, Fc Tag (Cat. No. ILR-H5256) with a linear range of 20-156 ng/mL (QC tested).

Binding affinity verified by SPR/BLI
Binding affinity verified by SPR/BLI

Anti-Human Integrin α 4 β 7 MAb, Human IgG1 (Cat. No. IN7-M525) captured on Protein A Chip can bind Human ITGA4&ITGB7 Heterodimer Protein, His Tag&Tag Free (Cat. No. IT7-H52W3) with an affinity constant of 3.46 nM as determined in a SPR assay (Biacore T200) (QC tested).

Binding affinity verified by SPR/BLI

Loaded Human PD-1 Protein, Fc Tag (Cat. No. PD1-H5257) on Protein A Biosensor, can bind Human PD-L1 Protein, His Tag (Cat. No. PD1-H5223) with an affinity constant of 3.4 μM as determined in BLI assay (ForteBio Octet Red96e) (QC tested).

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

2. 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

  • Introduction
  • Excellence in Quality Control and Assurance
  • Core Features
  • Product List
  • Verification Data
  • References