Polymerase Chain Reaction offers best DNA detection

With an ever-increasing demand for purity in pharmaceutical products, the identification of biological contaminants during the manufacturing process is an important consideration. Testing for bacterial, viral, and host-cell DNA is a required part of any biosafety plan. Lancaster Laboratories can help ensure the safety and efficacy of biopharmaceutical products using PCR-based technologies. PCR is a powerful technique that offers the ability to detect pathogens and residuals at higher sensitivity and greater specificity than other molecular-biology platforms. This is due to the nature of the PCR amplification process, which is theoretically capable of amplifying a gene of interest up to a trillion-fold over the course of one test. “PCR is a highly sensitive, fast, and cost-effective alternative to other detection methods,” says Dr. Amy Loercher, principal scientist. Moreover, Lancaster Labs is able to offer the advantage of quantitative PCR (qPCR), a fast, reliable, and efficient method that can determine exact amounts of genomic material in biopharmaceutical samples. Lancaster Labs uses qPCR systems from Applied Biosystems and performs all testing under cGMP conditions. Both absolute and relative-quantitation methods are available. Expert scientists can help design client projects, including the synthesis of custom primers, as well as assay development and PCR- validation methods. Sample extraction and data analysis are included as part of the service. Applications of PCR include: Residual-DNA Analysis Viral-DNA Identification Mycoplasma Testing Drug-Response Analysis Gene-Expression and Distribution Analysis For more information, please call Pharmaceutical Business Development at (717) 656-2300.