Microbiology testing

​​Mycoplasma ​are small, cell wall-free bacteria belonging to the Mollicutes class. ​​They are notorious contaminants in cell culture due to their ability to:​​ 

• ​​​Difficult to identify: They evade standard microscopic detection,​​ 
• ​​​Biological interferences: They alter cellular metabolism and functions, ​​ 
• ​​​Persistent survival: As a parasitic organisms, they exploit host cells for nutrients and growth​​ients and growth​​.

Why is Mycoplasma testing critical?​​

• ​​​Human and animal impact: Mycoplasma can infect humans, animals, and plants, causing respiratory and genital infections​​ 
• ​​​Bioproduction risks: Undetected contamination can compromise batch integrity and patient safety​​ 
• ​​​Regulatory guidelines: Global guidelines (EP 2.6.7, USP <63>) mandate rigorous mycoplasma testing during drug development and manufacturing.​

​​​Clean Cells offers comprehensive mycoplasma detection services, in line with GMP and non-GMP standards, ensuring the highest level of biosafety and regulatory compliance.​​

​​We integrate gold-standard compendial methods with cutting-edge rapid technologies, offering flexibility, reliability, and regulatory compliance for biopharma, vaccines, and cell & gene therapy developers.​ 

Why choose Clean Cells for Mycoplasma Testing?​​​​ 

• ​​​​20+ years of expertise​​ in mycoplasma detection and regulatory compliance​​

• ​​​​Comprehensive testing portfolio:​​ ​​Culture-based methods, PCR, and BIOFIRE® rapid PCR​​

• ​​​​GMP-compliant laboratories​​: ensuring ​​regulatory adherence and data reliability​​

• ​​​​Tailored solutions for biopharma, vaccine manufacturers, and cell & gene therapy developers​​

• ​​​​Expert validation services​​: supporting ​​BIOFIRE® implementation in your laboratory​​​​

Clean Cells, a Pioneer in Mycoplasma Detection for Biologics​​​​

​​​Since 2000, Clean Cells has been commited to the safety of biological products, in part by preventing mycoplasma contamination. These insidious micro-organisms represent a major risk to cell culture systems, biopharmaceutical production and patient safety, hence the importance of robust, compliant detection methods.​​​ 

​​​​Contact us​​ to discuss your mycoplasma testing needs and ensure the highest level of biosafety for your biologics!​​​ 

Microbiology testing ensures that biologics are free of bacterial and fungal agents. A basis of all biosafety testing programs to ensure the safety of patients, it is required by international medicine agencies at critical stages of biomanufacturing and carried out on starting material (cell line, media, etc.) that may carry contaminants. 

Probably the most common test of microbiology, a sterility test is mandatory for the release of any drug product. Thus, products must be demonstrated as sterile to meet specifications. 

Clean Cells has developed a panel of methods and approaches to assess the microbiological status of a drug product and its intermediates of production. Clean Cells’ offer covers a full range of cGMP-qualified microbiology tests applicable for all biologics including rapid microbial detection techniques more fitted to time sensitive products such as cell based therapies.

As a complementary test if sterility test or bioburden test appear to reveal a contamination, Clean Cells offer a service of identification.

Among the tests to detect bacterial contaminants in a drug product that will be injected into patients, sterility test and endotoxin quantification are probably the most classical ones. 

As defined by the National Institute of health (NIH), endotoxin refers to lipopolysaccharide (LPS) that constitutes the outer leaflet of the outer membrane of most Gram-negative bacteria such as E. Coli. The presence of LPS may reflect either a current contamination of the product or an infection that occurred during the production process although the bacteria is not alive anymore. Indeed, these endotoxins are toxins which can persist without viable microorganisms.

A key future of these toxins is that they may lead to fever (pyrogenic substances) and sepsis shock if they are injected into humans !  

Consequently, endotoxin testing and quantification is a prerequisite to injected biopharmaceuticals intravenously and are expressed in IU (international units). The acceptable level of endotoxins in a drug product will be determined according to the posology of treatment taking into account the weight of the patient and the duration of treatment ie IU/Kg of patient/ 24 hours. 

Hence a very precise quantification is necessary.

Mycobacteria belong to a specific category of bacteria: acid-alcohol resistant bacteria.

According to WHO: Human tuberculosis is still the greatest single cause of human morbidity and mortality in many developing countries. Mycobacterium tuberculosis (Kock bacillus) is the most frequent cause of human tuberculosis.

As a consequence, a detection of the potential presence of Mycobacteria spp is therefore required for the biosafety release of cell substrates used for the production of vaccines for human use (see EP chapter 5.2.3) and human vaccines (see chapter 2.6.16).

Our mycobacteria detection test panel includes: