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Molecular Diagnostics

The molecular diagnostic group at Custom Biologics is composed of senior scientists with over 25 years of combined experience in nucleic acid biochemistry.

Using Quantitative Fluorescence PCR, Custom Biologics has developed highly sensitive and rapid nucleic acid amplification and identification assays that are now employed in many areas of drug/biomarker discovery, biopharmaceutical drug development and lot release testing.

Quantifying the expression levels of genetic biomarkers in different human and animal cell types has led to the development of promising drug candidates and diagnostic tests for the food, veterinary and human health industries.

Services

Residual nucleic acid testing

Validated qPCR assays are routinely employed to quantify the residual levels of host cell nucleic acids in bio-pharmaceutical products (biologics and biosimilars) that have been produced in living organisms.  The methods and quantitation limits of our host cell nucleic assays adhere to the strict regulatory guidelines of the FDA, Word Health Organization and the United States Pharmacopeia.   Routine lot release testing is conducted under GMP guidelines.

Gene expression and biomarker analysis.

Customized quantitative fluorescent PCR assays have been employed in clinical trials and in-vitro studies to evaluate the expression levels of genetic biomarkers in normal and diseased cells in response to novel therapeutic agents. Multiplexing assays allow for the simultaneous and relative quantification of as many as five different genetic reactions.

Sterility/Mycoplasma testing

Mycoplasma contamination of mammalian cell cultures is a common and prevalent problem. At Custom Biologics, all cell lines employed in bioassay development and validation are tested for mycoplasma contamination using real time PCR. A rapid qPCR-based assay in place at Custom Biologics can detect and quantify as many as 13 of the most common mycoplasma species known to contaminate mammalian cell cultures.

Food Safety

A rapid isothermal nucleic acid amplification approach has been developed at Custom Biologics to quantify minute levels of bacterial contaminants in food products such as Listeria and E. coli. This method is currently undergoing third party validation as the next step to commercialization.