𝐸. 𝑐𝑜𝑙𝑖 Protein Production & Inclusion Body Refolding (ISO 13485)
E. coli remains the workhorse of recombinant protein production – cost-effective, scalable, and versatile. At ASKA Biotech, we specialize in overcoming the common challenges of bacterial expression. Whether you require soluble protein production or expert inclusion body refolding, our team develops a tailored process to maximize yield and purity. From genetic engineering to final purification, we ensure your microbial proteins meet the highest ISO 13485 quality standards for diagnostic and research applications.
Mastering Solubility, Purity, and Yield in 𝐸. 𝑐𝑜𝑙𝑖
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Inclusion Body Refolding: “Protein aggregated? No problem. We have established protocols for efficient solubilisation to recover bioactive proteins from inclusion bodies.”
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Endotoxin Removal: “Planning in vivo studies? We offer low-endotoxin purification (<0.1 EU/mg) to ensure your recombinant proteins are safe for animal models or cell assays.”
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Scalable Fermentation: “Need miligrams or grams? Our optimized processes maximize biomass and specific yield, scaling from shaker flasks to bioreactors.
Your Benefits with Our 𝐸. 𝑐𝑜𝑙𝑖 Expression Services
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Proprietary Refolding Protocols – We successfully recover bioactive proteins from inclusion bodies using optimized solubilisation strategies.
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Low Endotoxin Levels – High-purity manufacturing suitable for sensitive applications, cell-based assays, and in vivo studies.
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Scalable Fermentation – Optimized fed-batch processes to maximize biomass and specific protein yield (mg to gram scale).
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ISO 13485 Certified – Full traceability and documentation ensuring IVDR compliance for your diagnostic raw materials.
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Cost-Effective – The most economical route for producing large quantities of recombinant proteins without compromising quality.
Ready to Start Your 𝐸. 𝑐𝑜𝑙𝑖 Project? – Contact Us Now!
Do you need high-quality microbial proteins for your diagnostic or preclinical pipeline? Get in touch with us. Our experienced team will analyze your sequence, select the optimal strain, expression and purification strategy, and develop a tailor-made solution – fast, reliable, and compliant with ISO 13485 standards.
Looking for complex glycosylated proteins instead? Since bacteria cannot perform these modifications, we recommend our solutions for rapid mammalian expression (HEK) or scalable CHO manufacturing.
Our 𝐸. 𝑐𝑜𝑙𝑖 Capabilities at a Glance:
Technical Specifications & Capabilities
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Expression Strains – E. coli (Escherichia coli) BL21(DE3), and specialized strains for toxic proteins
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Affinity Tag Systems – His, GST, MBP, Strep (with optional enzymatic cleavage)
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Production Scale – Flexible scalability from mg research batches to gram-scale production
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Purity Grades – >90%, >95%, or >98% (SEC polishing available upon request)
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Quality Control (QC) – CGE, SDS-PAGE, SEC, and LAL-Test (Endotoxin determination)
FAQ - Frequently Asked Questions about 𝐸. 𝑐𝑜𝑙𝑖 Expression
My protein tends to form inclusion bodies. Can you handle this?
Absolutely. While many providers shy away from insoluble proteins in microbial protein production, we have established proprietary solubilization and refolding protocols to successfully recover bioactive proteins from E. coli inclusion bodies. We can also optimize the expression conditions upfront to promote soluble expression.
Are the proteins suitable for in vivo studies (animal trials)?
Yes. E. coli expression systems naturally produce endotoxins (LPS), which can be toxic in animal models. We offer a dedicated purification step to achieve low endotoxin levels (1 EU/mg or less upon request), ensuring maximum safety for cell-based assays and in vivo applications using your E. coli recombinant proteins.
What is the typical turnaround time for an 𝐸. 𝑐𝑜𝑙𝑖 project?
Standard 𝐸. 𝑐𝑜𝑙𝑖 recombinant protein production projects (from gene to purified protein) typically take 4 to 6 weeks. However, timelines for your custom protein expression can vary depending on the complexity of the protein and the required process optimization.
How much protein yield can I expect?
Yields in our bacterial 𝐸. 𝑐𝑜𝑙𝑖 expression system can range significantly – from a few milligrams to several grams per liter-depending on the protein’s toxicity and solubility. For a new project, we usually start with a small-scale pilot to determine the optimal conditions before scaling up.
Which 𝐸. 𝑐𝑜𝑙𝑖 strains and tags do you use?
For our 𝐸. 𝑐𝑜𝑙𝑖 expression services, we use established strains (e.g., BL21(DE3)) and common affinity tags (His, GST, Strep, MBP). All tags can be removed enzymatically if a native protein is required for your application.
Do you produce according to ISO 13485 standards for diagnostic use?
Yes, as your trusted German contract manufacturer (CMO), our entire facility and all 𝐸. 𝑐𝑜𝑙𝑖 protein production processes are ISO 13485 certified. We provide full documentation (including CoA and Batch Records) to fully support your IVDR approvals.
