Other Assays
Tumorigenicity
The tumorigenic potential of a cell line can be assessed by using either the in vivo nude mouse testing model, or in some cases, the in vitro soft agarose assay.
Oncogenicity
It is important to ensure that a cell substrate does not contain oncogenic potential. If a vaccine is manufactured in a cell substrate that was derived from a tumor or has a tumorigenic phenotype it could have a higher risk of containing oncogenic substances. Oncogenicity testing of cell lysates and DNA in rats, mice and hamsters is available.
Custom Assays
BioReliance offers custom services in Molecular Biology, Virology, Microbiology, and Analytical/ Bioanalytical including Clinical Trial Laboratory Services.
Our custom services include:
- New Assay Development
- Method Transfer, Validation and Qualification
- Assay Optimization
Additionally, we also offer Toxicology custom services. After consultation with one of our toxicology experts, we can define protocols to meet a number of custom parameters. We can customize standard assays to accommodate nearly any type of test article or analytical parameters required. At BioReliance every study protocol is custom designed to meet each study and customer’s specifications.
Want more information on our Custom Services? Please inquire at info@bioreliance.com or complete and submit a custom submission form.
RCR Assays
The possible presence of replication competent retroviruses (RCR) in gene therapy products intended for human use remains a major safety concern. RCR’s can develop at any step during manufacturing. Additionally, the growth of ex vivo- transduced cells provides the potential for amplification of any RCR contaminant, which can be below the level of detection in the retroviral vector supernatant. The current recommendations include testing of material from multiple stages of product manufacturing. BioReliance offers amplification and co-cultivation assays for RCR detection.
