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.
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.
| Professional Production Process | Superior Quality Standards |
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• 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. |
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).
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.
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).
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).
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).
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
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