The bioanalysis world has exploded with the need for molecular assays (qPCR, dPCR, NGS, Hybridization technologies) due to the demand for both biodistribution/PK and PD/BM analysis of various drug modalities. Many of these molecular assays have been around for decades and are now routine methods. CLIA and reference labs have…

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…

Arguably the most groundbreaking new opportunities for the treatment of disease and injury are Cell and Gene Therapy Products (CGTP) or what the European Medicines Agency (EMA) call Advanced Therapy Medicinal Products (ATMPs). EMA has broken down ATMPs into three main types: Gene therapy medicines: these…

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…