Endotoxin-Free Protein Production Service
Endotoxins, the lipopolysaccharide components of Gram-negative bacterial cell walls, can profoundly disrupt both in vitro and in vivo experiments even at trace levels. Residual endotoxin may alter protein tertiary structure, weaken antigen–antibody binding affinity, and produce misleading quantitative results. In animal studies, it can trigger nonspecific immune responses, fever, and inflammation, masking genuine effects. In biopharmaceutical manufacturing, uncontrolled endotoxin levels jeopardize product safety and stability, complicating regulatory approval. Our multi-stage endotoxin removal technology and rigorous quality control ensure the production of high-purity, ultra-low–endotoxin proteins, meeting the demands of preclinical animal research, precise cell-based assays, and various analytical applications, and guaranteeing reliable research and drug development outcomes.
Service Offerings
Creative Diagnostics delivers a one-stop solution for endotoxin-free protein production, from recombinant expression to purification and ready-to-use formulation. Using bacterial or mammalian expression systems, we perform large-scale fermentation or cell culture followed by multistep purification—affinity chromatography, ion-exchange, and size-exclusion—combined with physicochemical endotoxin removal. This process yields proteins with ≥90% purity and endotoxin levels well below industry standards. We also offer custom vector design, fusion-tag options, and buffer formulation, with sterile final packaging for direct use in vitro or in vivo.
Key Advantages
- Ultra-Low Endotoxin Levels: LAL testing confirms endotoxin content far below industry limits, minimizing immunogenic interference.
- High Protein Purity: ≥90% purity ensures high signal-to-noise and precise functional assays.
- Batch Consistency: Strict process monitoring and quality audits guarantee uniform performance across lots.
- Expert Team: Multidisciplinary specialists in molecular biology, fermentation engineering, analytical testing, and quality control oversee every step.
- Rapid Turnaround: Standardized workflows and ready-to-use formulations reduce experiment setup time.
- Flexible Customization: End-to-end solutions from vector design to formulation tailored to your needs.
Workflow
Define protein characteristics, purity/endotoxin specifications, and application requirements.
Select the optimal expression system, endotoxin removal strategy, and purification scheme.
Scale up fermentation or cell culture, followed by multistep purification and endotoxin elimination.
Perform SDS-PAGE, SEC, LAL endotoxin assays, activity measurements, and purity verification.
Adjust to target concentration and buffer conditions, package, and store refrigerated or frozen.
Provide complete QC reports and usage instructions, with technical consultation and follow-up assistance.
Considerations
- Storage: Store at –20 °C or –80 °C as specified; avoid repeated freeze–thaw cycles.
- Reconstitution: Gently reconstitute in recommended buffer; avoid vigorous shaking.
- Shipping: Maintain cold chain with dry ice or ice packs throughout transit.
- Experimental Design: Choose appropriate doses and controls based on endotoxin sensitivity.
- Safety: Follow biosafety and chemical handling guidelines.
For more information or custom solutions, please contact our technical support team.
