Biopharma Safety Testing (Mycoplasma, Endotoxins and Virus Testing)

SGS biopharma safety testing detects contamination of cell cultures, virus stocks and final products, with a view to assisting quality control measures in the development of biopharmaceutical products.

The threat of contamination of cell cultures by adventitious agents such as mycoplasma, endotoxin and viruses, should not be underestimated. Our services therefore test for a range of contaminants at any stage of drug development and production.

We test for:

• Mycoplasma, which can alter virtually every cellular process, including hybridoma selection rates, protein and nucleic acid synthesis, and immunogenicity and chromosomal damage
• Viral Contamination, which can lead to unreliable experiments in biomedical and biotechnological research and bring about significant productivity losses in biological manufacturing
• Endotoxins, which when present in a final product can induce an inflammatory response in patients

Tests for mycoplasma detection

• Cell culture method (21 CFR 610.30 and EP 2.6.7)
• Indicator cells and DNA
• Fluorochrome staining
• Validated PCR based method with pre-enrichment or direct detection
• Identification of Mycoplasma strains by DNA sequencing (in partnership with DNA Vision)

Endotoxin test methods

• LAL gel clot assay
• Photometric assay

Virus testing

• EP 2.6.16 and 5.2.3 and ICH Q5A
• In vitro adventitious virus assays by CPE, haemadsorption, and aemaglutination assay
• Virus titration by plaque assay

Sample materials

• Biopharmaceutical samples, including: raw materials, intermediate products, API, bulk drugs, and finished products
• Working and master cell banks
• Culture media

Conducted by our network of international experts, whose skills and knowledge are second to none, our biopharma safety testing methods are complaint with FDA, USP, EP and ICH guidelines, and also help you to ensure that your biopharmaceutical products meet other international and local regulatory requirements.

Contact our consultants to discuss how SGS could help with your biologics safety testing and produce data to ensure the best possible performance from your product during production and once it hits the market. As a world leader in tests for biopharmaceuticals, there is no organization better suited than SGS to meet your needs.

Lab ServicesLaboratory Services by SGSA comprehensive look at SGS’s global lab services (PDF 1,4MB) ...

MycoplasmaThe Hidden ThreatMycoplasma: The Hidden ThreatMycoplasma, their specific biology and detection (PDF 82KB) ...

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