Bacterial Endotoxin Analysis
Endotoxins, or lipopolysaccharides (LPS), are toxic components of Gram-negative bacterial cell walls and a common contaminant in proteins, biologics, and pharmaceuticals. These pyrogens are highly immunogenic — even at low levels — and can cause serious complications in both in vitro and in vivo applications. In cell cultures, endotoxins can suppress viability and skew transfection results. In animals or humans, they can induce fever, inflammation, endotoxin shock, organ damage, or even death.
To avoid these risks, strict regulatory limits apply. For example, the FDA mandates endotoxin levels in medical device eluates to be <0.5 EU/mL, and <0.06 EU/mL for devices contacting cerebrospinal fluid.
Removing endotoxins from injectables, biologics, and medical products is not optional—it’s essential.
Key Characteristics of Endotoxins
- Origin: Found in the outer membrane of Gram-negative bacteria
- Stability: Heat-resistant and difficult to eliminate
- Potency: Harmful even at microgram or nanogram levels
- Detection: Typically assessed using Bacterial Endotoxin Testing (BET)
Why Endotoxin Testing Matters
Endotoxin analysis is critical in:
- Injectable and parenteral drug products
- Radiopharmaceuticals and cytotoxics
- Water for Injection (WFI)
- Validation of depyrogenation processes
Common Sources of Endotoxin Contamination
- Water used in formulation or processing
- Raw materials and active ingredients
- Storage containers and preparation equipment
- Improper sterilization or depyrogenation processes
Endotoxin Detection Methods
Historical: Rabbit Pyrogen Test (RPT)
An outdated method where rabbits are injected with the test sample and monitored for fever. It’s qualitative, slow, and unsuitable for many product types.
Modern Standard: LAL Assay (Limulus Amoebocyte Lysate)
Derived from horseshoe crab blood, LAL reacts specifically with endotoxins, forming a gel or clot. It’s the industry gold standard for endotoxin detection.
LAL Assay Formats
- Gel-Clot Method : A qualitative or semi-quantitative test based on clot formation. Ideal for low-volume testing and regulatory pass/fail assessments.
- Turbidimetric Assay : Measures increasing turbidity as endotoxins trigger coagulin release. Results are read as changes in light absorbance or transmission.
- Chromogenic Assay : Uses a color-changing chromogen that responds to endotoxin presence. The intensity of color correlates with endotoxin concentration.
Need help with endotoxin testing or removal for your products?
Contact us at info@biosyn.com to learn how we can support your compliance and product safety needs
Why It Matters
Endotoxins—Lipopolysaccharides from Gram-negative bacteria—can wreck your experiments, kill cells, skew data, or shock animal subjects. If
you're working with proteins, peptides, antibodies, or nucleic acids for research, cell culture, or in vivo studies, you need endotoxin levels under
FDA limits (e.g., ≤0.5 EU/mL for most products, or ≤0.06 EU/mL for CNS applications). Anything else? That’s cutting corners—and risk
What We Offer
1. Endotoxin Testing
- LAL assay (gel-clot, chromogenic, turbidimetric) to detect and quantify endotoxin.
- Qualitative gel-clot test: around $250/test.
- Quantitative tests: from $1500/test, depending on your sample type.
- Purpose: Ensure endotoxin is below FDA limits (≤0.5 EU/mL in general or 0.06 EU/mL for CNS-contacting products)
2.Endotoxin Removal Approach for Oligonucleoitide)
Designed for when you need serious results—and fast.
Who Should Use This
- Biotech companies & CROs prepping biologics, injectables, and medical devices.
- Academic laboratories cleaning up samples for assays or injections.
- Cell-culture experts needing endotoxin-free proteins for sensitive experiments.
Get Started
Based in Lewisville, TX
Email: info@biosyn.com | 📞 Call: 972‑420‑8505
FAQs
Q: How fast is turnaround?
A: Testing only: 3–5 business days. Full-service: 7–14 days depending on sample type & batch size.
Q: Do I need to provide detailed sample data?
A: Yes. Concentration, buffer info, molecule type & quantity are essential for accurate service.
Q: What report comes with the service?
A: Full data package: LAL pre/post levels, removal %, recovery yield, SOPs for regulatory filing.
Choose us if you want clear–cut results—endotoxin-free molecules with intact payloads, documented and FDA-ready. No fluff. Just outcomes.
Endotoxin Removal Kits
Bacterial endotoxins (lipopolysaccharides, LPS) show strong biological effects in human, animal and cell cultures even at very low concentrations. Due to the high toxicity of bacterial endotoxins and DNA in vivo and in vitro, the removal of pyrogen from pharmaceutical products, recombinant proteins produced in E. Coli(or other gram-negative bacteria), and tissue culture media is of great importance for many applications.
Bio-Synthesis's Endotoxin Removal Kits are designed based on spin-column chromatography using Bio-Synthesis's innovative resin as the separation matrix. The sample can be easily purified from contaminating endotoxins within 20 minutes with a
recovery rate of >90%. Depending on the sample types, endotoxin levels are reduced to less than 0.1 EU to 0.01 EU/µg of DNA or protein.
- Endotoxin-Free DNA, Protein Peptides: Reduce endotoxin levels from 0.1 to 0.01 EU/µg or less
- Fast and easy processing: Effectively remove endotoxins in 20 minutes
- High Recovery: Over 90% recovery
- Ready-to-use: No need for lengthy column, resin buffer preparation
- No endotoxin carry-over: Unlike other gel-based endotoxin removal procedures, which
can lead to endotoxin carry-over. (Columns are single use only)
- Suitable for downstream applications: Purified protein is suitable for in vivo
and in vitro introduction into cells and organisms, monoclonal and polyclonal antibody
generation, mass spectrometry, gel electrophoresis, immunoassays, and Western blots
and purified DNA is fully compatible with sequencing, cloning and transfections.
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NB-23234
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Kanamycin Solution (10 mg/mL)
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Sterile Ready-to-Use Antibiotic Solution: Convenient cost effective and time saving
reagents manufactured under strict quality controls for reliability and consistency.
These high purity, endotoxin-free solutions are aliquoted for you which help you
avoid handling of toxic and harmful substances.
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NB-28233
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Ampicillin Solution (50 mg/mL)
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Sterile Ready-to-Use Antibiotic Solution: Convenient cost effective and time saving
reagents manufactured under strict quality controls for reliability and consistency.
These high purity, endotoxin-free solutions are aliquoted for you which help you
avoid handling of toxic and harmful substances.
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NB-28235
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Carbenicillin Solution (20 mg/mL)
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Sterile Ready-to-Use Carbenicillin Solution: Convenient cost effective and time
saving reagents manufactured under strict quality controls for reliability and consistency.
These high purity, endotoxin-free solutions are aliquoted for you which help you
avoid handling of toxic and harmful substances.
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NB-28237
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Tetracycline Solution (12.5 mg/mL)
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Sterile Ready-to-Use Tetracycline Solution: Convenient cost effective and time saving
reagents manufactured under strict quality controls for reliability and consistency.
These high purity, endotoxin-free solutions are aliquoted for you which help you
avoid handling of toxic and harmful substances.
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NB-22800
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ProteoSpin Endotoxin Removal Micro Kit
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Protein Purification Kits: ProteoSpin Endotoxin Removal Micro Kit and Protein Purification
Kits provide rapid and efficient endotoxin removal from proteins and peptides.
Rapid and convenient spin column format columns bind proteins of interest while
endotoxins flow-through Reduce endotoxin levels.
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NB-22200
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ProteoSpin Endotoxin Removal Maxi Kit
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Protein Purification Kits: ProteoSpin Endotoxin Removal Maxi Kit and Protein Purification
Kits provide rapid and efficient endotoxin removal from proteins and peptides.
Rapid and convenient spin column format columns bind proteins of interest while
endotoxins flow-through Reduce endotoxin levels.
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NB-23800
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CleanAll RNA/DNA Clean-Up and Concentration Kit
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This kit can be used to clean up DNA from digestions, ligations, PCR reactions,
labeling reactions, DNA modification reactions and staining.
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NB-22700
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Endotoxin Removal Kit (Mini) - For DNA
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Endotoxin Removal Kit (Mini) - This DNA purification kit is used for rapid removal
of endotoxins from previously purified DNA. It can reduce endotoxin levels to 0.1
EU/µg DNA or less and can effectively remove endotoxins in as little as 20 minutes.
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NB-21900
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Endotoxin Removal Kit (Maxi) - For DNA
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Endotoxin Removal Kit (Maxi) - This DNA purification kit is used for rapid removal
of endotoxins from up to 1 mg of previously purified DNA. It can reduce endotoxin
levels to 0.1 EU/µg DNA or less and can effectively remove endotoxins in as little
as 30 minutes.
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NB-15300
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Plasmid DNA Maxiprep Kit
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Provides a rapid method for the preparation of large quantities of high quality
plasmid DNA. Typical yields from a 100 mL culture for a high copy number plasmid
are between 0.4 and 1.0 mg, with final endotoxin levels of 0.1 EU/µg of DNA or less.
The kit can be used to purify plasmids up to 13,000 bp in size.
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