Platforms
- ABI Prismä 7900 (96 well, 384 well, and low density fluidic card capacity)
- Roche LightCycler 480 System II
- Field Inversion Gel Electrophoresis System
Applications
Biodistribution Studies
Our custom real time PCR analysis performed in a GLP environment provides a powerful tool for assessing the safety and efficacy of nucleic acid therapeutics. These studies determine the distribution of the gene or vaccine therapy to tissue sites other than the intended therapeutic site. This addresses both regulatory and scientific concerns by providing information on the safety of the vector, the gene it transports, and the expression of the specific transgene.
Integration Studies:
Our custom designed real time PCR analysis, coupled with agarose gel size fractionation, provides a powerful tool for assessing the possibility of plasmid vector integration into genomic DNA. It addresses both regulatory and scientific concerns by providing information on the safety of the vector, the possibility of insertional mutagenesis, and the possibility of germline transfer.
Host Cell DNA Contamination Assays:
Real time PCR assays designed to determine the amount of host cell DNA contamination in viral and protein preparations. These tests offer crucial information to researchers and manufacturers that can be used to detect DNA from a wide range of cell lines including humans, mice, primates and hamsters.
Adventitious Virus Testing:
Adventitious agents in vaccines and therapeutics is a significant concern to regulatory agencies. Our ultrasensitive qualified assays ensure the highest standard of safety is maintained throughout the manufacturing process.