Life Sciences Adventitious Agent and Virus Testing Services
Adventitious agent and mycoplasma testing services from SGS – biologics safety testing to ensure that your cell cultures, virus stocks and final products are certified free from contaminating agents, such as endotoxins and viruses.
During the development of your biopharmaceutical products, the threat of cell culture contamination by adventitious agents such as mycoplasma, endotoxins and viruses, should not be underestimated. We offer you comprehensive testing for a range of contaminants at every stage of your drug development and production process.
Why choose adventitious agent and mycoplasma testing services from SGS?
Our testing services include endotoxin testing, biologics safety testing, mycoplasma testing and in vitro adventitious virus assays.
We can help you:
- Improve your quality control measures for biopharmaceutical product development
- Gain precise data to ensure the best possible performance from your product
- Detect mycoplasma, which can alter virtually every cellular process, including hybridoma selection rates, protein and nucleic acid synthesis, and immunogenicity and chromosomal damage
- Identify viral contamination to prevent the distortion of biomedical and biotechnological product research and clinical evaluation, and avoid productivity losses in biological manufacturing
- Reveal endotoxins to prevent their presence in the end product, avoiding the risk of inflammatory responses in patients
- Ensure that your biopharmaceutical products meet international and local regulatory requirements
Adventitious agent and mycoplasma testing services from a world leader
As a world leader in biologics testing, there is no organization better suited to meet your needs. Conducted by our network of international experts, whose skills and knowledge are second to none, our biopharma safety testing methods are compliant with a broad range of regulations. These include the Food and Drug Administration (FDA), the U.S. Pharmacopeial Convention (USP), European Pharmacopoeia, and The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.
We offer you a comprehensive range of adventitious agent and mycoplasma testing services as listed below.
Our tests for mycoplasma include:
- Cell culture method (21 CFR 610.30 and EP 2.6.7)
- Indicator cells and DNA
- Fluorochrome staining
- Validated polymerase chain reaction (PCR) based method with pre-enrichment or direct detection
- Identification of mycoplasma strains by DNA sequencing (in partnership with DNA Vision)
Endotoxin test methods
Our endotoxin testing includes:
- Limulus amebocyte lysate (LAL) gel clot assay
- Photometric assay
Our virus test methods include:
- EP 2.6.16 and 5.2.3 and ICH Q5A
- In vitro adventitious virus assays by cytopathic effects (CPE), haemadsorption, and aemaglutination assay
- Virus titration by plaque assay
We provide a wide range of sample materials, including:
- Biopharmaceutical samples, including: raw materials, intermediate products, active pharmaceutical ingredient (API), bulk drugs, and finished products
- Working and master cell banks
- Culture media
To find out more about our adventitious agent and mycoplasma testing services, contact us today.
Detection of Mycoplasma
Mycoplasma are too small to be seen under a standard lab microscope, yet the contamination problem is significant in bio-therapeutic and vaccine manufacturing.