PCR-based assays are increasingly utilized for bioanalysis to support the development of a wide variety of therapeutics. While the largest driver for this growth has been the expanding pipeline of cell, gene, and RNA therapies, PCR-based assays are also seeing increased use in biomarker detection across all therapeutic modalities. These…

Polymerase Chain Reaction (PCR) has revolutionized molecular biology by enabling the rapid and precise amplification of DNA sequences. Since its invention by Kary Mullis in the 1980s, PCR has become an indispensable tool in both research and diagnostic applications. From identifying genetic disorders to detecting infectious diseases, PCR’s versatility has…

Polymerase chain reaction (PCR) assays (including digital PCR and quantitative PCR) can be used to detect and measure nucleic acids such as DNA, RNA, small RNAs, and non-coding RNAs. What may be surprising is how few guidelines and whitepapers are available for bioanalytical support for regulated Bioanalysis by dPCR and…

When you examine how to develop and validate/qualify a Biodistribution assay by PCR…

Two of the scientific experts from KCAS Bio have been leaders in determining the direction of qPCR and ddPCR technology for the industry. Carrie Vyhlidal, PhD and Jonathan Mercier are both part of the American Association of Pharmaceutical Scientists’ working group for PCR-based methodology, and they have recently…