DNA will be extracted from test article and host control cells followed by spectrophotometry quantification and gel electrophoresis analysis. If needed, target-specific and genomic qPCR assays will be developed and qualified. Standard curves will be prepared for both target-specific and genomic assays, respectively. For each test article, six dilutions will be analyzed in duplicate along with Positive Control, Negative Control, and No Template Control using the ABI 7900 HT Fast Real-Time PCR System. Copy number of the target gene per cell will be reported.
Custom assays may be developed and validated per ICH guidelines.
- Staff experienced in offering both GMP and GLP genomic services
- Method validated per ICH guidelines
- Both qPCR raw data and data analysis included in report
- Professional project report readily accepted by regulatory agencies worldwide
- Excellent customer service focuses on client communication
- Competitive price
- Turn-around time is 4 weeks