Pichia Residual DNA Detection Kit (qPCR)
Pichia Residual DNA Detection Kit (qPCR)
✓ Regulatory-Compliant: Meets USP/EP/ChP standards for biologics quality control (≤10 ng/dose).
✓ GMP-Ready Solution: Pre-validated kit with full documentation for pharmaceutical QC applications.
The Bluekit Pichia Residual DNA Detection Kit (qPCR) is designed for quantitative detection of residual host cell DNA from Pichia pastoris in biological products, drug intermediates, semi-finished and finished products.
This kit utilizes TaqMan probe-based qPCR technology, offering rapid detection, high specificity and reliable performance with sensitivity down to femtogram levels.
General Workflow
1. Sample Preparation
Input Material: Purified biologics (vaccines, therapeutic proteins, etc.) or process intermediates.
DNA Extraction: Use a validated method (e.g., column-based or magnetic bead extraction) to isolate residual DNA.
Elution: Resuspend DNA in nuclease-free water or TE buffer (10–50 µL).
2. qPCR Setup (Using HG-PD001 Kit)
Reaction Mix:
Prepare master mix containing:
qPCR buffer (with dNTPs, Mg²⁺, stabilizers)
Pichia-specific primers/probe (included)
DNA polymerase (hot-start, high-fidelity)
Internal control (optional, for inhibition monitoring)
Standards: Run a 5-point standard curve (e.g., 10 ng/µL – 3 fg/µL) in duplicate.
Samples/Loading: Add 2–5 µL of extracted DNA per well (96-well plate format).
3. qPCR Run
Cycling Conditions (Typical):
Initial Denaturation: 95°C, 2 min
40 Cycles: 95°C (15 sec) → 60°C (1 min, fluorescence read)
Platform: Compatible with major real-time PCR systems (e.g., ABI 7500, Roche LightCycler®).
4. Data Analysis
Quantification: Calculate DNA concentration (fg/µL) from the standard curve (R² ≥ 0.98).
Acceptance Criteria:
Negative Control: No amplification (Cq > 40).
Positive Control: Cq within ±1 cycle of expected value.
Sample CV: ≤25% for replicates.
Reporting: Compare results to pharmacopeial limits (e.g., ≤10 ng/dose).
5. Documentation & Compliance
Records: Document all steps per ALCOA+ principles (GMP).
Validation: Include system suitability, LOD/LOQ, and precision data in reports.
Shipping Information
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Shipping Time: Orders are typically processed within 1-3 business days. Once your order has been shipped, you’ll receive a confirmation email with tracking information.
Important Information
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Note:As our product falls under the special category, returns and refunds are not accepted.
