Products derived from transgenic organisms, for use as human or animal drugs or for biologics are regulated by the FDA for safety and efficacy. The FDA requires Southern blots to confirm that the structure of the genomic DNA of a cell bank is stable and unchanged and that no clonal rearrangement has occurred. Southern blots also confirm target identity as matching the hybridization probe, size as compared to a molecular weight marker, and abundance. Northern blots confirm the gene expression pattern of a cell bank.
Avance Biosciences provides all necessary expertise for Southern or Northern blot projects from nucleotide extraction to probe design. We offer Southern blot analysis to support gene discovery and confirmation, gene mapping, evolution and development studies, diagnostics, and forensics tests. Transcript Analysis by Northern Blot service is offered to detect the presence of an expressed transcript containing a sequence of interest. The size of the transcript will be estimated and the presence of partial transcripts will be reported. Both Radiative and chemiluminescent detection chemistries are offered.
Genomics & Biological Services
Experienced scientists functioning as project managers or study directors
Independent quality unit assuring regulatory compliance
Methods validated per ICH GLP/GMP guidelines – also research grade testing available
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Controlled laboratory environment to prevent cross-contamination