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Bacterial and Fungal Testing – Culture Method
Culture-based bacterial and fungal testing for cell culture and biological sample quality control.
Description
Cell & Gene Therapy QC
Bacterial and Fungal Testing – Culture Method
Culture-based bacterial and fungal sterility testing for cell-therapy products and cell-culture supernatants. Provides Pharmacopoeia-aligned evidence of microbiological contamination.
Sample Types
- Cell culture supernatant
- Final cell-therapy product
- In-process samples
Measured Targets
- Aerobic bacteria
- Anaerobic bacteria
- Yeasts
- Filamentous fungi
Workflow
- Step 1. Inoculate fluid thioglycollate medium (anaerobes) and soy-bean casein digest medium (aerobes / fungi).
- Step 2. Incubate per pharmacopoeia (typically 14 days at the specified temperatures).
- Step 3. Daily turbidity inspection.
- Step 4. Identify any growth and report sterile / contaminated.
Quality Features
- Stable
Closed-tube reaction, no carryover - Reliable
Internal control catches false-negatives - Convenient
Simple setup, no electrophoresis step - Quantitative
Ct-based readout, comparable runs
Catalog Information & Documentation
Catalog number, pack size, validation data, IFU, and shipment terms are provided on request. BioWing supplies cold-chain shipping (−20 ℃) and a one-year shelf life when stored at −20 ℃.
For sample requirements, turnaround time, or technical consultation, please contact our team.
Request a Quote or Sample-Submission Form
Email market@biowing.com.cn or call +86-21-3355 9491 — we typically reply within one business day.
