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Product Description
A sandwich-format solid-phase ELISA for quantitative detection of residual nonspecific endonuclease (SMNE) in bioprocess samples. The assay uses a sheep polyclonal anti-SMNE capture antibody coated on microtiter strips, a biotinylated anti-SMNE detection antibody and streptavidin-HRP. Signal is developed with TMB substrate and read at 450 nm (with 620–650 nm reference). The kit can detect genetically engineered Serratia marcescens endonucleases (e.g., Benzonase®) and is intended for research use only (not for clinical diagnostics).
Technical Specifications
| Parameter | Details |
|---|---|
| Assay format | Sandwich ELISA (solid-phase double-antibody sandwich) |
| Measurement wavelength | 450 nm (reference 620–650 nm) |
| Linearity & range | 0.1–25 ng/mL (R² ≥ 0.990) |
| Lower limit of quantification (LLOQ) | 0.25 ng/mL |
| Specificity / Cross-reactivity | No cross-reactivity with RNase, host cell proteins (E. coli, CHO, HEK293T, Vero cells) or BSA |
| Calibration model | 4-parameter logistic (4-PL) regression. Example curve parameters provided (A=4.08707; B=-1.00169; C=30.95401; D=0.00166; R²=0.99997) |
| Typical sample types | In-process samples, harvested bulk, drug substance, drug product (samples must be clear/transparent; remove particulates by centrifugation/filtration) |
| Minimum recommended pipetting volume | 5 µL minimum recommended for dilution accuracy |
| Plate layout / throughput | 96 tests per kit (8 wells × 12 strips) |
Features
- High specificity: Sheep polyclonal antibody pair selective for SMNE; no cross-reactivity with common RNases, host cell proteins or BSA.
- Sensitive quantitation: Low LLOQ (0.25 ng/mL) and linear range down to 0.1 ng/mL for detection of residual endonuclease.
- Ready-to-use coated strips: Pre-coated microtiter strips provided in a sealed bag with desiccant for convenience and reduced hands-on preparation.
- Standardized protocol: Complete workflow with recommended dilutions, incubation times, and 4‑PL curve fitting for reliable quantitation.
- Process monitoring application: Designed for quantitation of SMNE in bioprocess purification stages, including detection of engineered endonucleases such as Benzonase®.
Applications
- Quantitation of residual SMNE (Serratia marcescens endonuclease) during bioprocess purification
- Monitoring endonuclease removal in in-process samples and harvested bulk
- Testing drug substance and drug product for residual endonuclease impurities
- Method validation and QC support during downstream processing (research use)
Kit Contents
SMNE Calibration standard (PNB004) 1 × 100 μL2-8 °C (store up to 12 months; follow label instructions)
Anti-SMNE Microtiter Strips (PNA004) 8 wells × 12 strips2-8 °C in sealed bag with desiccant (store up to 30 days after opening)
SMNE Diluent (PNE003) 2 × 25 mL2-8 °C
Wash Buffer Concentrate (10×) (PNF001) 2 × 25 mL2-8 °C (dilute 10× → 1× with ultra-pure water prior to use)
Anti-SMNE: Biotinylated Conjugate (100×) (PNG004) 1 × 120 μL2-8 °C (centrifuge before use; dilute 100× in diluent immediately prior to use)
Streptavidin-HRP (100×) (PNH002) 1 × 140 μL2-8 °C; keep sealed and protected from light (dilute 100× in diluent immediately prior to use)
TMB Substrate (PND003) 1 × 12 mL2-8 °C; sealed and protected from light; equilibrate to room temperature 20 min before use
Stop Solution (PNI002) 1 × 6 mL (1 M HCl)2-8 °C (corrosive; handle with PPE)
Sealing Film (PNK001) 3 piecesRoom temperature
* Total: 96 tests/Kit | Method: ELISA (sandwich double-antibody)
Attention
• For research use only (not for clinical diagnostic use).
• Store the kit at 2–8 °C. Check individual component labels and recommended storage after opening.
• Equilibrate kit reagents to room temperature for 20 minutes before use; return to 2–8 °C immediately after use.
• Avoid repeated freeze-thaw cycles of samples; for long-term storage use ≤ -70 °C.
• Do not mix reagents from different lot numbers.
• Use fresh ultra-pure water; water temperature should not exceed 37 °C when preparing buffers.
• Avoid samples containing sodium azide (NaN3) — it will inactivate HRP and cause underestimation.
• Sorbitol may cause high background; sample sorbitol concentration should not exceed 0.01%.
• Maintain sample pH between 6.5 and 8.5 to avoid assay interference.
• Prepare Biotinylated antibody and Streptavidin-HRP dilutions fresh for each assay; recommended for single use due to stability.
• Stop Solution is 1 M HCl — corrosive: avoid contact with eyes, skin, and clothing; wear goggles and appropriate PPE.
• Complete plate reading within 30 minutes after termination.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the intended use of this kit?
The kit is intended for quantitative measurement of nonspecific endonuclease (SMNE) in bioprocess samples (in-process material, harvested bulk, drug substance and drug product). It is for research use only and not for clinical diagnostics.
Q2: What is the assay sensitivity and working range?
Linear range 0.1–25 ng/mL with a reported LLOQ of 0.25 ng/mL; a 4-parameter logistic (4-PL) regression is used for quantitation.
Q3: Can the kit detect Benzonase® or other engineered Serratia marcescens endonucleases?
Yes — the kit is designed to detect genetically engineered endonucleases from Serratia marcescens, such as Benzonase®.
Q4: How should I store opened components and how long are they stable?
Store the kit at 2–8 °C. Calibration standard is stable at 2–8 °C for up to 12 months (check tube label); opened microtiter strips stored with desiccant at 2–8 °C are stable up to 30 days. Other reagents should be used according to label and prepared fresh where indicated.
Research Use Only
✔
For Research Use Only (RUO); not intended for clinical use. – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.
✔
Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
