This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|January 25, 2023
Qualtrak Real-Time PCR and Digital PCR Ecosystem for Streamlined Biologics Development
Author(s)Thermo Fisher Scientific
Developing and manufacturing biologics requires compliant technologies and methods that provide excellent accuracy, consistency, and quality control (QC) with continuous automation potential to ensure the best possible product is delivered in the right time frame. PCR methods that enable quantification of target nucleic acid sequences—namely quantitative real-time PCR (qPCR) and digital PCR (dPCR)—have become core technologies for delivering high-quality results in a range of applications throughout biologics development and biomanufacturing. qPCR and dPCR methods are the gold standards for sensitive, specific detection and quantification of nucleic acid targets, which are useful for QC testing a wide variety of biologic characteristics.
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