From routine pre-clinical batches to routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of biologics prior to release for use in animals and humans, which is a key part of the Regulatory Document Chemistry and Manufacturing Control (CMC) regulatory.
Creative Biolabs offers a wide range of contamination testing for the detection of mycoplasma and bacterial contaminants, as well as in vivo, in vitro and biochemical viral assays. Our experts work with you to identify sources of contamination and design available and customized testing solutions tailored to your specific needs. After that, we can work with you to conduct new quality control checks in batch testing, and optimize product development methods and raw material analysis to minimize future safety issues.
Cell substrates used in biological agents must be demonstrated to be free of foreign factors including mycoplasma. Mycoplasma contamination of cell lines can affect cell growth in culture and also affect biomolecule production. Mycoplasma testing services:
Creative Biolabs provides sterility testing in accordance with USP and EP regulations. Bulk or final products are sterility tested by direct inoculation or membrane filtration methods and can be performed in an isolator or clean room environments.
Direct inoculation of the medium for sterility testing:
Membrane filtration sterility test:
These test methods can also be developed and consulted according to specific products.
Creative Biolabs offers a range of in vivo, in vitro and biochemical viral safety analyses. You can select and customize analysis to meet your specific concerns and needs, ensuring that you have the right test plan for your product.
In vivo detection
Cell-based in vitro assay
Feel free to contact us for project quotations and more detailed information.
For lab research only, cannot be used for any clinical use.