Endotoxins are the active components of lipopolysaccharides (LPS) in the cell walls of Gram-negative bacteria, which can impact the safety and performance of pharmaceuticals, biologics, and laboratory reagents even at trace levels. Therefore, endotoxin testing is critical in drug development and production to ensure product quality, experimental reliability, and development efficiency. BOC Sciences detects endotoxins using highly sensitive bioassays, including LAL, rFC, and MAT, converting LPS presence into measurable signals. We provide comprehensive testing across pharmaceuticals, biologics, cell and gene therapy products, and water systems, delivering precise, reproducible, and high-throughput results that help clients monitor quality, reduce contamination risks, and accelerate R&D progress.
We provide precise detection and quantification of endotoxins in diverse sample types. At BOC Sciences, our validated methods ensure reliable, reproducible results, supporting product safety, experimental accuracy, and seamless integration into your research or manufacturing workflow.
We provide expert guidance on method selection, validation protocols, and experimental design. Our consulting ensures optimized testing workflows, accurate interpretation of results, and technical support tailored to your research or production needs.
We implement ongoing QC programs including batch release testing, standard curve verification, and continuous monitoring. Our approach guarantees consistent product quality, reliable assay performance, and confidence in every measurement and production batch.
BOC Sciences provides professional endotoxin testing with reliable results and flexible options to support diverse sample types and project goals.
Using traditional LAL reagents, this method induces gel formation in the presence of endotoxins. It is simple to operate, suitable for semi-quantitative batch screening, and commonly applied in preliminary testing of pharmaceuticals and medical devices.
This method measures color change proportional to endotoxin concentration using 405 nm absorbance. Offering high sensitivity (0.005–50 EU/mL), it is ideal for precise quantification in injectable drugs, vaccines, and other products requiring accurate endotoxin analysis.
Endotoxin levels are quantified by monitoring turbidity increase over time. It is less affected by optical interference and suitable for transparent or slightly turbid samples, providing reliable results for diverse sample types.
Employing recombinant Factor C protein in a single-step enzymatic reaction with colorimetric or fluorescent readout, this method avoids horseshoe crab-derived reagents, is environmentally friendly, and is insensitive to β-glucan interference, meeting strict animal-free project requirements.
Using human monocytes or PBMCs, this method measures cytokine release (IL- 1β, IL- 6) in response to endotoxins and other pyrogens. It can detect non-endotoxin pyrogens and aligns with EU guidelines for animal testing alternatives.
This specialized LAL-based assay detects β- glucans to prevent interference with endotoxin results. It is particularly suitable for samples containing fungal components or polysaccharides, ensuring accurate endotoxin measurement.
BOC Sciences provides comprehensive endotoxin testing across key applications, ensuring product safety, quality control, and process reliability.
Provide your sample specifications, and BOC Sciences will offer expert guidance and high-quality endotoxin testing tailored to your workflow.
Clients provide sample information and testing objectives. Our specialists discuss goals and recommend a tailored endotoxin testing strategy.
Clients submit samples with relevant details. We perform quality checks and confirm sample integrity before initiating testing.
Our laboratory conducts endotoxin assays using validated methods. Results are carefully analyzed and interpreted by experienced scientists.
A comprehensive report, including data interpretation, is generated and promptly delivered to the client in electronic format.
BOC Sciences provides tailored endotoxin testing services for biopharmaceutical products, including monoclonal antibodies, vaccines, and recombinant proteins. Our solutions deliver precise quantification and actionable insights, supporting process optimization and quality assurance throughout the drug development lifecycle.
We provide endotoxin testing tailored to formulation studies, supporting excipient compatibility and stability assessment. Our precise analytical services help clients identify contamination risks, optimize formulations, and maintain product quality throughout development.
BOC Sciences delivers targeted endotoxin analysis to optimize manufacturing processes. By monitoring raw materials, intermediates, and final products, we help clients reduce contamination, improve yield, and ensure consistency, enhancing efficiency in bioprocess and pharmaceutical production.
Our endotoxin testing services support preclinical studies and safety evaluations by providing rapid, sensitive, and reliable detection. We assist clients in validating product safety, guiding dose selection, and ensuring accurate risk assessment for early-stage drug candidates.
Partner with BOC Sciences to perform precise endotoxin analysis for your raw materials, APIs, and final formulations. Our experienced scientists provide fast, dependable results, enabling confident decision-making in your development workflow.
Our endotoxin testing workflow ensures fast turnaround times without compromising accuracy, handling diverse sample types from biologics to raw materials with consistently reproducible results.
Leveraging state-of-the-art detection platforms, we achieve low-level endotoxin quantification, reliably detecting trace contaminants even in complex formulations.
We handle a diverse range of sample matrices, from protein therapeutics to environmental samples, delivering reliable and consistent performance across multiple industries.
Our team delivers detailed, actionable reports, integrating multi-dimensional analysis for clear interpretation, helping clients make informed quality control decisions efficiently.
Client Needs: A biopharmaceutical company developing monoclonal antibodies required precise endotoxin quantification in early-stage formulations to ensure batch consistency and avoid immune response interference in downstream pharmacology studies.
Challenges: The client faced inconsistent endotoxin readings due to high protein concentrations and complex excipient combinations, which made it difficult to compare batches reliably. Their internal testing methods failed to detect low-level contamination, delaying formulation decisions. Additionally, the client needed rapid results to keep multiple formulation iterations on schedule, but their existing processes could not support high-throughput demands.
Solution: BOC Sciences applied a combination of kinetic chromogenic LAL assays and sample dilution strategies to mitigate matrix interference. Parallel spike recovery and inhibition testing validated accuracy, while automation enabled high-throughput assessment.
Outcome: Delivered reliable endotoxin profiles for all formulations, allowing the client to optimize buffers and protein stabilization confidently. High-confidence data accelerated formulation refinement and reduced decision-making delays.
Client Needs: A pharmaceutical developer required sensitive endotoxin detection in lipid nanoparticle (LNP) formulations used for nucleic acid delivery to guide quality assessment of multiple experimental batches.
Challenges: The client struggled to detect low-level endotoxin contamination because the lipid-rich matrix masked signals, leading to uncertainty in batch quality. They were unable to compare multiple LNP formulations reliably, which slowed experimental planning and risked proceeding with suboptimal batches. High variability between internal tests made it difficult for the client to make informed process adjustments.
Solution: BOC Sciences employed a validated recombinant factor C assay with optimized extraction and dilution protocols. Internal controls and batch comparisons ensured reproducible results across varied LNP compositions.
Outcome: Consistent endotoxin profiles allowed the client to identify subtle batch differences and refine manufacturing parameters, maintaining high-quality experimental material for research.
Client Needs: A small-molecule drug discovery company sought rapid endotoxin assessment of multiple injectable candidates to prioritize safe compounds for in vivo pharmacology studies.
Challenges: The client found that diverse solubility profiles and excipient combinations caused interference in endotoxin readings, making it hard to rank candidates accurately. Their internal assays lacked sensitivity for low-level contamination, and throughput limitations delayed decision-making, risking bottlenecks in candidate selection. They needed robust, reproducible data to confidently advance compounds.
Solution: BOC Sciences implemented a multiplexed chromogenic LAL testing workflow with tailored sample preparation. Spike recovery validation and automated handling supported high-throughput, interference-resistant assessment.
Outcome: The client could rank injectable candidates efficiently, accelerate compound prioritization, and reduce the risk of advancing contaminated candidates, streamlining downstream pharmacological evaluation.
An endotoxin test measures the presence of LPS released by Gram-negative bacteria in a product. It provides precise quantification of trace endotoxins to ensure the quality and consistency of biologics, drug carriers, and laboratory reagents. The LAL assay is one of the most widely used detection methods. BOC Sciences offers a robust endotoxin testing platform with high sensitivity and reproducibility, helping clients quickly assess the endotoxin levels in their products.
Endotoxin testing is essential for any product involving biologics, drug delivery systems, protein formulations, or cell culture reagents. Products intended for in vitro experiments or bioprocess development are particularly sensitive to endotoxin contamination, which can impact results or downstream processes. Professional endotoxin testing allows companies to monitor product safety early, reducing potential risks and ensuring experimental reliability.
The endotoxin limit test determines the maximum allowable endotoxin concentration for a specific product based on its characteristics and intended use. It provides quantitative data to verify whether a product meets endotoxin specifications and supports process optimization. BOC Sciences can provide customized endotoxin limit testing solutions tailored to various product types, delivering reliable and comparable results for your evaluation.
Endotoxin testing is essential for water used in pharmaceutical and bioprocess applications, particularly water that comes into direct contact with sterile products or manufacturing equipment. Key types include water for injection, purified water, reverse osmosis water, and process water used in production lines. Regular endotoxin monitoring ensures that water quality meets required standards, prevents contamination of drug products or biologics, and supports consistent, safe manufacturing processes. BOC Sciences provides reliable endotoxin testing for various water types, helping clients maintain compliance and safeguard product integrity.
High-quality endotoxin testing provides accurate, reproducible data that support process optimization and experimental design. Systematic testing allows developers to identify potential issues, adjust parameters, or select appropriate raw materials, improving product consistency and reliability. BOC Sciences leverages advanced testing technologies and expert teams to deliver comprehensive endotoxin evaluation services, assisting clients in making informed development decisions.
The endotoxin testing service provided by BOC Sciences has proven extremely reliable. Their comprehensive approach to assay validation and sensitivity assessment ensured that we received trustworthy results for every batch tested. This reliability has been critical for our internal process evaluations.
— Dr. S., Senior Scientist, Biopharmaceutical Company
BOC Sciences' endotoxin testing consistently yields precise and reproducible data. The thorough methodology and attention to assay conditions allowed us to make informed decisions with confidence, streamlining our upstream development workflows.
— Dr. M., Head of Process Development, Contract Research Organization
We have been impressed with BOC Sciences' technical expertise in endotoxin testing. Their team provided clear guidance on assay design and troubleshooting, ensuring that our analytical results were accurate and consistent across multiple product lines.
— Dr. K., Lead Analytical Scientist, Specialty Biotech Firm
The endotoxin testing service from BOC Sciences offers detailed analytical insights beyond standard readings. Their thorough approach to sample handling and result interpretation has enhanced our understanding of potential process variability, improving our overall product evaluation.
— Dr. R., Director of Analytical Development, Mid-sized Biopharma Company
