01 Mycoplasma Detection: An Invisible Risk That Cannot Be Ignored in Cell Product QC

In the production of biopharmaceuticals and cell therapy products, mycoplasma contamination is regarded as one of the most insidious microbial risks that also draw high regulatory attention. Mycoplasma can grow persistently at low levels in cell culture systems. It generally does not cause turbidity in culture media, and is hard to detect in a timely manner via conventional microscopy or traditional microbial testing methods.

Once contamination occurs, it will adversely affect cell growth characteristics, process consistency, as well as the quality and safety of final products. Therefore, mycoplasma detection has always been a critical test item in the quality control (QC) system for biological and cell therapy products.

02 Practical Challenges of Traditional Culture Methods

With the rapid development of cell therapy, viral vectors and personalized products, the traditional 28-day culture method faces growing challenges in actual production and product release:

• Long testing cycle, which fails to match short release timelines

• Large sample volume required, incompatible with high-value products

• Unable to support rapid decision-making and in-process control

  
  

Figure 1: Comparison of Turnaround Time Between Mycoplasma Culture Method and Molecular Detection

Against this backdrop, QC laboratories require mycoplasma detection solutions that are not only compliant with regulations, but also efficient, stable and sustainable.

03 Integrated Solution Tailored for QC Scenarios

The value of rapid detection lies not only in shorter testing time, but also in enabling QC teams to obtain stable and traceable data within a limited time frame for reliable judgment.

Huzhou Shenke Biotechnology Co., Ltd. (HZSKBIO^®) has developed an integrated solution centered on the all-in-one rapid mycoplasma detector and dedicated NAT (Nucleic Acid Amplification Testing) reagent cartridges based on real-world application scenarios of QC laboratories. This solution realizes high integration covering the entire workflow from sample processing to result output.

Table 1: QC Decision Performance of Different Technical Methods

04 Core Advantages of AdvSHENTEK^® Integrated Rapid Mycoplasma Detection Solution

4.1 Automated Magnetic Bead-Based Nucleic Acid Extraction

Adopting mature magnetic bead capture and elution technology, the system efficiently extracts mycoplasma nucleic acids. It also effectively removes potential inhibitory substances from culture systems and complex matrices, providing high-quality templates for subsequent amplification and detection.

4.2 Pre-packaged Reagent Cartridge Design

All functional reagents are pre-encapsulated in disposable test cartridges. This design eliminates operational discrepancies caused by manual reagent preparation, simplifies testing procedures and reduces the risk of cross-contamination.

4.3 Full-volume Sampling to Ensure LOD ≤ 10 CFU/mL

The system supports maximum 1 mL full-volume sample loading, which avoids detection deviations caused by uneven sampling and irregular distribution of bacterial colonies. It achieves a Limit of Detection (LOD) of ≤ 10 CFU/mL stably, even when testing low-GC strains and samples containing up to 10⁷ cells.

4.4 Fully Closed and Integrated Full Workflow

After sample loading, the system automatically completes the whole process including nucleic acid extraction, amplification and detection. Manual intervention is minimized to improve testing consistency and data reliability, making it perfectly suitable for long-term stable operation in GMP-compliant QC laboratories.

Figure 2: Workflow of AdvSHENTEK^® Mycoplasma Detection

4.5 Rapid Turnaround Time to Support Timely Decision-Making

Final results can be generated within 2.5–3 hours for the entire testing workflow. Compared with the traditional culture method, the testing cycle is greatly shortened, which is especially applicable to cell therapy and other scenarios with tight product release schedules.

4.6 User-friendly Data Management & Audit Compliance

The system supports automatic recording and export of test results, facilitating QC document filing, result review and audit trails. It ensures data integrity and standardizes quality management under the GMP system.

Figure 3: Integration of AdvSHENTEK^®-4 into Production Workflow

05 More Than Speed: Enhanced QC Capabilities for Better Adaptability

For high-value products such as cell products, mycoplasma detection is not merely a regulatory compliance item, but also a key link in supply scheduling and quality control systems.

Featuring highly integrated automation, the AdvSHENTEK^® integrated rapid mycoplasma detection solution empowers QC laboratories with the following strengths:

• Improved testing efficiency

• Reduced operational complexity

• Higher consistency and traceability of test results

• Better compatibility with the supply rhythm of modern biological and cell products

Table 2: Overview of AdvSHENTEK^® Mycoplasma Detection Validation

*Only validation summaries are shown. Please contact us for detailed validation data.

The core value of rapid mycoplasma detection extends far beyond faster testing speed. More importantly, it helps build a repeatable, auditable and sustainably operable QC workflow.

As an integrated rapid detection solution, AdvSHENTEK^® effectively matches QC workflows with production rhythms, while guaranteeing the traceability and reliability of test data. It delivers stable and verifiable quality assurance for enterprises.