Breaking Dependence on Imported High-End QC Reagents: Yeasen and NIFDC Publish Landmark Paper on Rapid Mycoplasma Detection Technology

SHANGHAI — China's biomedical industry took a significant step toward self-reliance in quality control reagents this week, as Yisheng Biotechnology (Shanghai) Co., Ltd. announced the publication of a landmark research paper on rapid mycoplasma detection technology, developed in collaboration with the National Institutes for Food and Drug Control (NIFDC).

The paper, titled "Establishment of Nucleic Acid Amplification Technology for the Detection of Mycoplasma in Biological Products," marks a critical milestone in upgrading China's mycoplasma quality control system for biological products—and signals a potential shift away from dependence on imported high-end testing reagents.

For the biopharmaceutical industry, mycoplasma contamination represents one of the most persistent safety risks throughout the production of cell therapies, vaccines, gene drugs, and other biological products. Traditional culture-based detection methods, which can require up to 28 days for results, have struggled to keep pace with the rapid expansion of the cell and gene therapy (CGT) sector, where shorter product shelf lives demand faster, more precise quality control solutions.

Nucleic acid amplification technology (NAT) has emerged as the industry's preferred alternative, offering superior sensitivity, speed, and throughput. While European, Japanese, and U.S. pharmacopoeias have already incorporated NAT methods for mycoplasma detection, China's 2020 Pharmacopoeia has yet to formally adopt the approach—though it permits "other methods approved by national drug testing institutions."

The collaborative research between NIFDC and Yeasen—known in the industry as a leading domestic manufacturer of tool enzymes and molecular diagnostic reagents—sought to bridge this gap. The partnership combined NIFDC's regulatory expertise and compliance standards with Yeasen's core enzyme materials, reagent systems, and extensive operational validation data.

According to the published research, the team conducted comprehensive methodological validation against domestic biological product quality control regulations, testing specificity, sensitivity, repeatability, and anti-interference performance. The resulting detection protocol demonstrated strong stability and superior sensitivity, capable of accurately identifying various common mycoplasma contamination strains across multiple biological product categories, including antibody drugs, cell preparations, lentiviral vectors, recombinant proteins, and vaccines.

The product also features a non-infectious positive control to eliminate contamination risks and an internal control system to exclude sample interference and reaction preparation errors, effectively preventing false-negative results. The kit can be paired with Yeasen's MolPure® Magnetic Bead Residual DNA Sample Pretreatment Kit for nucleic acid extraction, compatible with both manual processing and automated nucleic acid extractors.

Yeasen, founded in 2014, has established itself as a high-tech enterprise focused on upstream core materials for the life science industry chain. The company develops, produces, and sells products across four major categories: nucleotides, proteins, cells, and organoids. With thousands of core products spanning molecular cloning, qPCR, next-generation sequencing, in vitro transcription, antibodies, protein purification and analysis, cell culture, transfection, reporter gene detection, organoids, and GLP-1 core materials, Yeasen serves applications in life science research, diagnostic testing, biopharmaceuticals, and general health.

Since its establishment, Yeasen has focused on upstream core tool research and development in the biopharmaceutical sector, collaborating with NIFDC, regional drug testing institutes, leading pharmaceutical companies, and university research centers on standards development and joint research initiatives. From participating in group standard formulation to producing high-level academic achievements alongside national authoritative institutions, the company has progressively leveraged its core technology capabilities to support the elevation of domestic biosafety quality control standards.

Looking ahead, Yeasen plans to continue investing in quality control technology iteration for hot sectors including CGT and vaccines, developing higher-performance, full-scenario coverage solutions for mycoplasma, virus, and host DNA residual detection. The company also aims to deepen industry-academia-research collaborative innovation with national authoritative platforms and industry partners, applying domestic core technology to safeguard the safety of Chinese biological products and support the high-quality, standardized development of China's biopharmaceutical industry.

The regulatory landscape continues to evolve. While the 2020 Chinese Pharmacopoeia has not yet formally incorporated NAT methods for mycoplasma detection, the May 2022 guidance from the Center for Drug Evaluation explicitly permits novel detection methods when pharmacopoeia methods prove insufficient for immune cell therapy products, provided they undergo full validation. This regulatory flexibility, combined with demonstrated technical capabilities from domestic suppliers like Yeasen, suggests that NAT-based mycoplasma detection methods are poised for broader adoption across China's rapidly expanding biopharmaceutical manufacturing sector.

For raw material suppliers and advanced therapy medicinal product (ATMP) companies alike, the message is clear: rapid, sensitive, and compliant mycoplasma detection solutions are no longer a future aspiration—they are an operational necessity, and domestic suppliers are now positioned to deliver.