Rapid, sensitive mycoplasma detection for cell therapies, biologics, and biomanufacturing workflows, fully aligned with GMP and European Pharmacopoeia requirements (EP 10.1 chapter 2.6.7 Mycoplasmas).
Mycoplasma testing is a critical quality control step in the development and manufacturing of biologics, vaccines, viral vectors, and advanced therapy medicinal products (ATMPs).
Mycoplasma are small bacteria lacking a cell wall that can contaminate cell cultures without visible signs, making them particularly difficult to detect. BaseClear provides a highly sensitive mycoplasma detection service designed to identify contamination early and ensure compliance with GMP manufacturing and regulatory expectations.
Our laboratory performs mycoplasma testing in accordance with the European Pharmacopoeia (EP) chapter 2.6.7, as referenced in EP Edition 10.1, using validated detection workflows suitable for regulated biopharmaceutical environments.
GMP-compliant mycoplasma testing is essential for organizations developing or manufacturing biological products. Our services support:
Mycoplasma testing is commonly required for cell banks, production cell lines, raw materials, in-process samples, and final product release testing.
BaseClear uses validated NAT detection technology designed to identify a broad range of mycoplasma species known to contaminate mammalian cell cultures. This workflow provide rapid detection while maintaining sensitivity and reliability required for GMP applications.
Testing workflows include:
This allows rapid and reliable detection while meeting pharmacopeial performance requirements
Clients receive a GMP-compliant report that can be directly used in regulatory documentation or quality systems.
Our specialists evaluate your project, regulatory requirements, and sample type to design the appropriate mycoplasma testing strategy.
Preferably, we assess the need for matrix validation to ensure the detection method performs reliably in your specific sample matrix.
You submit sample matrixes or samples such as supernatants, following our specifications.
If applicable, we perform matrix feasibility testing (method suitability testing) to confirm that the GMP-compliant mycoplasma detection assay performs reliably in your specific sample matrix. This step verifies that potential inhibitors or matrix effects do not affect assay sensitivity or detection performance.
Once matrix suitability is confirmed, samples are analysed using PCR-based validated mycoplasma detection method aligned with European Pharmacopoeia 10.1 EP 2.6.7 and GxP quality systems.
You receive a comprehensive analytical report suitable for quality documentation, regulatory submissions, and manufacturing release testing.
Bacterial species in validated database
Fungal species in validated database
Fast track turnaround available
End-to-end MicroSEQ® workflow
Mycoplasma contamination is the presence of bacteria from the Mollicutes class that lack a cell wall and frequently infect mammalian cell cultures. Because they are extremely small and do not cause visible turbidity in culture media, contamination often goes undetected without specialized testing. Mycoplasma infections can alter cellular metabolism, affect experimental outcomes, and compromise the safety of biopharmaceutical products.
Mycoplasma testing for biologics and cell-based products is required under pharmacopeial standards including European Pharmacopoeia chapter 2.6.7, USP <63>, and related GMP guidelines. These regulations specify validated detection methods and performance criteria for ensuring the absence of mycoplasma contamination.
Mycoplasma testing is typically required for master cell banks, working cell banks, production cell lines, raw materials of biological origin, in-process samples, and final drug products. Testing may also be required during routine cell culture maintenance or before initiating manufacturing campaigns.
Molecular detection methods can identify mycoplasma DNA within a few hours once testing begins. Rapid PCR-based workflows significantly reduce detection time compared with traditional culture-based methods, while maintaining the sensitivity required for regulated environments.
Validated molecular assays are designed to detect a wide spectrum of mycoplasma species known to contaminate cell cultures, including common contaminants such as Mycoplasma hyorhinis, Mycoplasma orale, and Mycoplasma pneumoniae, Mycoplasma arginini, Mycoplasma Synoviae, Mycoplasma fermentans, Archoleplasma laidlawii and Spiroplasma citri. Broad detection coverage is essential for reliable quality control.
Mycoplasma testing is essential for advanced therapy medicinal products (ATMPs) because contamination can directly impact patient safety and product efficacy. Regulatory authorities therefore require validated testing of cell banks and production materials before clinical use.
Verify the identity of cell lines using sequencing analysis.
Quantify the residual host cell DNA in your samples using digital PCR technology.
Schedule a free consultation with our experts to discuss your testing needs and regulatory requirements. We’ll help design a compliant testing workflow for your project.
