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| Product Name | Recombinant Enterokinase Light Chain, GMP Grade with Polyhistidine Tag (5 U/uL) |
| Catalog No. | IVDRM-0293 |
| Description | Where a protease is used in preparing material that moves towards clinical manufacture, analytical purity is not enough: the impurity profile has to be documented. This version of the enterokinase light chain is produced under GMP rules with a full quality dossier available, and it is specified not only on activity and identity but also on endotoxin below 1 EU per microgram, host cell protein no higher than 0.01% and residual host DNA no higher than 10 ng per milligram. The biochemistry is otherwise unchanged from the research-grade enzyme: the same recombinant light chain secreted by Komagataella phaffii, the same exclusive cleavage after Asp-Asp-Asp-Asp-Lys, the same wide pH window from 4.5 to 9.5, and the same polyhistidine tag for removal on nickel resin once digestion is complete. |
| Intended Use | Tag removal during process development and manufacture where documented impurity control is required, and any high-sensitivity digestion work needing low endotoxin input. |
| Principle / Technology | Identical to the research-grade enzyme: hydrolysis of the bond following the lysine of the Asp-Asp-Asp-Asp-Lys recognition sequence, with specificity preserved by the recombinant light chain. |
| Detection Method | Does not apply; performance is judged by the downstream assay rather than by this product. |
| Sample Type | Fusion proteins destined for further processing where residual impurities must be controlled. |
| Performance Range / Specifications | Manufactured under GMP to ISO 13485 with traceable quality documentation; endotoxin below 1 EU per microgram; host protein at or under 0.01%; host DNA at or under 10 ng per mg; specificity for Asp-Asp-Asp-Asp-Lys; activity from pH 4.5 to 9.5 with polyhistidine removal afterwards. |
| Sensitivity / LOD | Does not apply; sensitivity comes from the downstream detection chemistry. |
| Specificity | 5 U/uL; theoretical mass 22.7 kDa with an apparent 40 kDa band from glycosylation; purity at least 95%; endotoxin below 1 EU per microgram; host protein not above 0.01%; host DNA not above 10 ng per mg. |
| Reaction Conditions / Protocol | Run the digestion at 25 °C for 12 to 16 hours in 20 mM Tris-HCl with 50 mM sodium chloride and 2 mM calcium chloride at pH 8.0 using the documented enzyme-to-substrate ratio, then remove the polyhistidine tagged enzyme on a nickel column. |
| Components / Formulation | Bottled enzyme at 5 U/uL; supplied in 5000 U, 100 KU and 1 MU (1000 KU) quantities. |
| Storage Conditions | Store at -25 to -15 °C. |
| Shelf Life | 2 years from receipt when stored as recommended. |
| Package Specifications | Liquid enzyme supplied to give 5000 U, 100 KU or 1 MU (1000 KU). |
| Product Form | Sterile liquid in glycerol-containing buffer. |
| Quality Control | Released against activity, purity, identity, endotoxin, host protein and residual DNA criteria, supported by manufacturing records. |
| Key Features | - Manufactured under GMP to ISO 13485 with quality documentation available - Endotoxin below 1 EU per microgram - Host cell protein at or below 0.01% - Residual host DNA at or below 10 ng per mg - Unchanged Asp-Asp-Asp-Asp-Lys specificity with removable polyhistidine tag |
| Purity | At least 95% with no other proteolytic activity detectable. |
| Concentration | 5 U/uL. |
| Activity / Unit Definition | Unit defined as the amount cleaving 95% of 50 ug of a roughly 64.6 kDa fusion substrate in 12 to 16 hours at 25 °C. |
| Molecular Weight | Theoretical 22.7 kDa; apparent about 40 kDa owing to glycosylation. |
| Source / Origin | Recombinant expression in Komagataella phaffii (Pichia pastoris) with animal-free inputs. |
| pH Range / Optimal pH | Supplied at pH 8.0 in 50 mM Tris-HCl, 250 mM sodium chloride, 2 mM calcium chloride, 50% glycerol. |
| Shipping Conditions | Shipped cold with temperature monitoring appropriate to the grade. |
| Expiration Date / Stability | Remains usable for the full shelf life provided the temperature recommendation is followed. |
| Regulatory / Compliance | Supplied for laboratory research purposes. |
| Compatibility | Same digestion and nickel removal workflow as the research-grade enzyme, with impurity levels suited to regulated use. |
| Recommended Buffer System | Storage solution as above; reaction recommended in the reduced-salt digestion buffer. |
| Application Notes / Precautions | Plan the enzyme amount from the defined unit rather than assuming a simple scale-down; smaller substrates are cut more readily than the large reference protein. |
| Batch-to-Batch Consistency | Lot-to-lot consistency is maintained through defined manufacturing specifications; every lot ships with its release record. |
| Model Type | Documented-grade fusion tag protease |
| Starting Material / Tissue Site | GMP-manufactured recombinant light chain from Komagataella phaffii |
| Delivery Standard | Vials sized to the ordered unit quantity with accompanying quality documents |
| Turnaround Time | dispatch is arranged at order confirmation. |
| Readouts / Downstream Assays | Tag removal followed by SDS-PAGE or liquid chromatography, plus impurity levels in the processed material. |
For in vitro diagnostic use.
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