Rigorous sterility testing
At Qkine our products are thoroughly screened for microbial and mycoplasma contamination.
Mycoplasmas represent a group of microorganisms that are characterized by their lack of a rigid cell wall. They are one of the smallest self-replicating organisms known and can subsequently pass through anti-bacteriological filters. They represent a major challenge in cell culture laboratories as they can produce a variety of effects on cells, are resistant to most antibiotics and can impact the reliability and reproducibility of experimental results. For this reason, it is crucial that all reagents purchased for stem cell culture have been tested for the absence of mycoplasma.
Getting the simple things right is important.
At Qkine, we are committed to raising the standard in bioactive protein manufacturing.
Our science team is here to help, please contact us if you have any questions at customerservice@qkine.com.
Mycoplasma testing
All Qkine proteins are tested for the presence of mycoplasma in two assays. The first is a selective biochemical test that exploits the activity of mycoplasmal enzymes which are found in the vast majority of about 200 mycoplasma species but are not present in eukaryotic cells. The bioluminescence is measured and can detect contamination from Mycoplasma, Acholeplasma, Entomoplasma and Spiroplasma.
We also use a PCR-based method to amplify the conserved 16S ribosomal RNA coding region within mycoplasma genomes, thereby providing an extensive, highly sensitive, and efficient detection method. This test detects three genera of Mycoplasmatales – Mycoplasma, Acholeplasma, and Ureaplasma.
Sterility testing
To ensure no contamination from bacteria or fungi, we carry out sterility testing in anaerobic and aerobic conditions through direct inoculation of fluid thioglycolate medium (FTM) and tryptic soy broth (TSB) and a 14 day incubation protocol followed by turbidity testing.
This test is based on US Pharmacopoeia 71, EU Pharmacopoeia 2.6.1, and JP Pharmacopoeia 4.06 requirements.
Positive controls of Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Aspergillus brasilensis, Bacillus spizizenii and Staphylococcus aureus are included alongside each test.
