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Product Description
Solid-phase enzyme-linked immunosorbent assay (one-step double-antibody sandwich ELISA) for quantitative determination of residual host cell proteins (HCPs) originating from the CHO-K1 cell line. The assay uses an affinity-purified sheep polyclonal capture antibody coated on microtiter strips and an HRP-labeled anti-CHO-K1 HCP detection antibody added simultaneously with calibration standards or samples. TMB substrate is used for color development (blue at 655 nm; stopped reaction yields yellow product measured at 450 nm). Sample concentrations are calculated from a 4-parameter logistic dose-response calibration curve.
Technical Specifications
| Parameter | Details |
|---|---|
| Assay format | One-step double-antibody sandwich ELISA (pre-coated microtiter strips) |
| Package size | 96 tests/Kit |
| Linearity & Range | 3 - 300 ng/mL, R² ≥ 0.990 |
| Lower Limit of Quantification (LLOQ) | 3 ng/mL |
| Specificity | No cross-reactivity with Sf9, HEK 293T, E.coli BL21, P. pastoris HCP |
| Typical read wavelength | 450 nm (reference/correction 620–650 nm) |
| Incubation | Sample/reagent incubation: 3 hours at room temperature on thermoshaker (600 rpm); TMB development: 15 minutes at RT |
| Sample pH range | Recommended pH 6.5–8.5 |
| Storage (opened components) | Microtiter strips in sealed bag with desiccant: 2–8 °C up to 60 days; Reconstituted calibration standard: aliquot and store ≤ -20 °C up to 60 days (avoid freeze-thaw) |
| Calibration model | 4-parameter logistic regression |
Features
- CHO-K1 specific detection: Sheep polyclonal antibodies raised against CHO-K1 HCPs provide specific capture and detection of residual CHO-K1 host cell proteins.
- One-step ELISA workflow: Simultaneous addition of HRP-labeled detection antibody with standards/samples simplifies setup and reduces handling steps.
- Pre-coated strips: Microtiter strips come pre-coated with affinity-purified capture antibody and packaged with desiccant for convenience and consistency.
- Sensitive and wide dynamic range: Validated linear range 3–300 ng/mL with LLOQ 3 ng/mL and R² ≥ 0.990.
- Minimal cross-reactivity: No detectable cross-reactivity with common alternative expression hosts (Sf9, HEK293T, E.coli BL21, P.pastoris).
Applications
- Quantification of residual CHO-K1 host cell proteins in process intermediates
- Testing of harvested bulk, drug substance and drug product derived from CHO-K1 cells
- Method validation and recovery/spike studies for HCP measurement
- Research QC and bioprocess monitoring in development labs
Kit Contents
Anti-CHO-K1 HCP Microtiter Strips (pre-coated)Sealed bag with desiccant, store at 2-8 °C (stable up to 60 days after opening)
CHO-K1 HCP Calibration Standard (lyophilized)2 bottles, reconstitute with 500 µL Reconstitution Solution; aliquot and store ≤ -20 °C (stable up to 60 days)
Reconstitution Solution1 × 1.5 mL, room temperature equilibration before use
Diluent2 × 25 mL, store at 2-8 °C
Wash Buffer Concentrate (10×)2 × 25 mL, dilute 1:10 with ultra-pure water; store at 2-8 °C
Anti-CHO-K1 HCP:HRP (100×)1 × 120 µL, affinity-purified HRP-conjugated sheep antibody; dilute 100× in Diluent before use; store at 2-8 °C
TMB Substrate1 × 12 mL, protect from light; equilibrate to RT 20 min before use; store at 2-8 °C
Stop Solution (sulfuric acid)1 × 12 mL, corrosive—avoid contact; store at 2-8 °C
Sealing Film3 pieces, store at 2-8 °C
* Total: 96 tests/Kit | Method: ELISA
Attention
• For research use only (not for clinical diagnostic use).
• Intended for qualified laboratory personnel only.
• Validate assay and sample dilution strategy before routine testing.
• Use single-use consumables; wipe work surfaces and equipment with 75% ethanol when appropriate.
• Avoid repeated freeze–thaw cycles of samples and standards; long-term sample storage recommended at ≤ -70 °C.
• Do not mix reagents from different lot numbers.
• TMB substrate should be colorless before use; discard if colored.
• Stop Solution is sulfuric acid — avoid contact with eyes, skin and clothing; follow chemical safety procedures.
• Avoid sodium azide (NaN3) in samples or reagents (it inactivates HRP).
• Prepare 1×Wash Buffer fresh from 10× concentrate; ensure solutions are clear (heat to 37 °C to dissolve precipitate if needed).
• Read plate within 30 minutes after stopping the reaction.
• Minimum recommended pipetting volume for dilutions: 5 µL to reduce error.
Quality Management & Certifications
Quality System
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Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the assay range and sensitivity?
The validated linear range is 3–300 ng/mL with an LLOQ of 3 ng/mL (R² ≥ 0.990).
Q2: Can this kit detect HCPs from non-CHO-K1 expression hosts?
This kit is specifically designed for CHO-K1-derived HCPs; no cross-reactivity was observed with Sf9, HEK293T, E. coli BL21 or P. pastoris HCPs, so it is not recommended for quantifying HCPs from those hosts.
Q3: How should samples and reconstituted standards be stored?
Long-term sample storage is recommended at ≤ -70 °C to prevent degradation. Reconstituted calibration standards should be aliquoted and stored at ≤ -20 °C and used within 60 days; avoid repeated freeze–thaw cycles.
Q4: Are there any reagents or sample components to avoid?
Avoid sodium azide in samples or reagents (it will deactivate HRP). Do not use samples outside recommended pH range (6.5–8.5) as this may cause abnormal results.
Research Use Only
✔
Research Use Only (RUO) – 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.
