| Field | Specification |
|---|---|
| Mfr No | |
| Product Type | |
| Shipping | |
| Storage |
Description
Hansenula polymorpha Host Cell DNA Residue Detection Kit is used for the quantitative analysis of Hansenula polymorpha host cell DNA residuce in intermediate samples, semi-finished and finished products of various biological products.
This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual Hansenula polymorpha cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES).
Feature
- Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
- Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
- High sensitivity: the limit of quantification can reach 3 fg/μL level;
- High precision: high intra-batch repeatability and low inter-batch variation;
- Strong exclusivity: specific detection of residual DNA in Hansenula polymorpha cells without interference from other exogenous genomic DNA;
- Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors.
Application
Residual Hansenula polymorpha Host Cell DNA test in biological products.
Specification
|
Sensitivity |
3 fg/μL (range 30fg/μL~300pg/μL) |
|
Assay Time |
~1.5 hours |
|
Assay Principle |
Fluorescent probe qPCR method |
|
Required Instruments |
Real-time fluorescence quantitative PCR system |
Components
|
Components No. |
Name |
41317ES50-EN |
41317ES60-EN |
|
41317-A |
Hansenula polymorpha qPCR Mix |
0.75 mL |
1.5 mL |
|
41317-B |
Hansenula polymorpha Primer&Probe Mix |
200 μL |
400 μL |
|
41317-C |
DNA Dilution Buffer |
1.8 mL×2 |
1.8 mL×4 |
|
41317-D |
Hansenula polymorpha DNA Control (30 ng/μL) |
25 μL |
50 μL |
|
41317-E |
IC* |
50 μL |
100 μL |
*IC：Internal control.
Storage
This product should be stored at -25~-15℃ for 2 years.
Both 41317-A and 41317-B should be stored protected from light.
Figures
- Limit of quantification
Hansenula polymorpha DNA was detected at 30 fg/uL, 10 fg/uL, 5 fg/uL, and 3 fg/uL, with 10 replicates for each concentration. The results showed that at concentrations of 3fg/uL and above, the CV was <20%, i.e., the limit of quantification for DNA residues in Hansenula host cells was 3fg/uL.
|
Repetition number Test item |
Hansenula polymorpha DNA (fg/uL) |
|
|
Quantity |
Return ratio |
|
|
1 |
3.25 |
108.33% |
|
2 |
2.69 |
89.67% |
|
3 |
3.41 |
113.67% |
|
4 |
3.46 |
115.33% |
|
5 |
2.98 |
99.33% |
|
6 |
2.81 |
93.67% |
|
7 |
2.89 |
96.33% |
|
8 |
2.79 |
93.00% |
|
9 |
3.35 |
111.67% |
|
10 |
2.80 |
93.33% |
|
Average value |
3.04 |
\ |
|
CV% |
9.64% |
\ |
Table 1. Limit of quantification (LOQ) assay results for Hansenula polymorpha yeast DNA
Documents:
—
What regulatory guidelines govern host cell DNA residue testing?
Host cell DNA (HCD) residue testing is required for biopharmaceutical manufacturing under ICH Q5A, ICH Q6B, FDA 21 CFR Part 610, and EMA guidelines. Acceptable residual HCD limits are typically ≤10 ng/dose (WHO guideline) or ≤100 pg/dose for continuous cell line-derived products, depending on the product class and route of administration. This kit provides qPCR-based quantification traceable to validated reference standards.
How does this kit achieve host cell-specific detection?
This kit uses primers and probes targeting genome-specific repetitive elements (e.g., Alu elements for human HEK293/CHO, LINE-1 for mammalian cells, or species-specific rDNA repeats for yeast/insect cell lines) that are highly conserved and abundant in the host genome. This provides high sensitivity — typically detecting sub-picogram quantities of residual host DNA — without cross-reacting with the target product or plasmid sequences.
Can this kit be used for lot release or stability studies?
Yes. The quantitative qPCR format of this kit is suitable for lot release testing, process characterization, and stability monitoring of biopharmaceutical drug substances and drug products. To generate regulatory-compliant data, assay performance qualification (sensitivity, specificity, linearity, spike recovery) should be documented per applicable guidelines. Contact your QA team to confirm kit suitability for your specific regulatory submission.
What is the limit of detection (LOD) of this host cell DNA detection kit?
The LOD varies by kit generation and target cell line (e.g., HEK293, CHO, E. coli, Pichia pastoris). Third-generation (3G) kits typically achieve LOD values of 0.1–1 pg of host cell DNA per reaction. The validated linear range spans 4–6 orders of magnitude, supporting both low-level process monitoring and high-level spiking experiments. Validated LOD and LOQ values are provided in the product-specific datasheet.
Yeasen Biotechnology offers flexible customization options for many of its assay kits and detection reagents, including custom lot sizes, bulk ordering, and application-specific formulation adjustments. Volume pricing, custom packaging, and kit bundling may be available depending on the product and intended workflow. A Certificate of Analysis (CoA) and lot-specific QC data are provided with every order. For inquiries regarding large-volume orders, custom configurations, or integration into automated workflows, please contact the BioHippo team for a tailored quotation.
10%
OFF
15%OFF
20%
OFF
$50
OFF
FREE
SAMPLE
