Mycoplasma Detection

Mycoplasma Detection is a critical safety control measure for biopharmaceuticals, cell & gene therapies, vaccines and recombinant protein products. Mycoplasma are cell-wall-free microorganisms that can evade standard sterilization processes, causing cellular dysfunction, reduced product stability, gene expression changes and potential clinical risks. Fully aligned with ChP, USP and EP pharmacopeial requirements, this test is a mandatory inspection item for cell substrates, viral vectors, bulk drugs and final bioproducts, enabling early risk control, batch consistency assurance and smooth GMP, registration and cross-border audit access.

PharmaAnalytica's mycoplasma detection solutions cover full-scenario biopharmaceutical applications and fully compliant testing indicators. The scope includes cell cultures, viral vaccines, monoclonal antibodies, recombinant proteins, cell & gene therapy products, as well as raw materials and process fluids for biomanufacturing.

Our core testing covers universal mycoplasma screening and specified strain identification, including M. orale, M. pneumoniae, M. fermentans, A. laidlawii and other common contaminating species. All methods are officially authorized by major pharmacopeias:

• Nucleic Acid Amplification Technology (NAT): For high-sensitivity, high-throughput rapid screening (USP <122>, EP 2.6.33)
• Culture Method: As the gold-standard confirmatory test for definitive identification and quantitative results (USP <63>, EP 2.6.7)
• Indicator Cell Staining Method: For auxiliary morphological verification and contamination localization (USP <63>, EP 2.6.7)

PharmaAnalytica's Technology Platform

PharmaAnalytica's Mycoplasma Detection Service

As a specialized testing brand under STEMart, PharmaAnalytica delivers compliant, efficient and customized one-stop mycoplasma detection solutions to support biopharmaceutical enterprises in GMP compliance and product commercialization.

Expert Technical Team

Our testing team consists of certified professionals in biopharmaceutical microbiology and cell culture, with in-depth knowledge of USP, EP guidelines and long-term GLP/GMP laboratory experience. They efficiently manage complex samples such as high-density cell cultures and antibody drugs, minimizing operational variability.

Comprehensive Method Suitability & Interference Assessment

Before formal testing, mandatory matrix interference and inhibition tests are performed for each sample type. Optimized dilution and pretreatment procedures eliminate matrix effects, ensuring results are accurate, reliable and fully pharmacopeia‑compliant.

Full-Chain Data Governance & Auditable Reports

The entire testing workflow uses automated data acquisition, real-time audit trail and electronic signature locking. Original data, amplification curves, culture records and fluorescence images are securely archived. We provide official bilingual reports that satisfy domestic registration, GMP inspections and global market filing requirements.

Tailored Flexible Service Model

We design personalized mycoplasma testing strategies based on product category, production phase and project schedule. We flexibly adjust sample preparation, detection methods and turnaround time, supported by full‑life‑cycle services including pre-test consultation, real‑time progress update and post-test technical support, significantly reducing compliance costs.

Partner with PharmaAnalytica under STEMart for trusted, compliant and efficient mycoplasma detection, and accelerate your biopharmaceutical quality control and global regulatory approval with confidence.