QualTrak Real-Time PCR And Digital PCR Ecosystem For Streamlined Biologics Development

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. Leveraging these versatile technologies is imperative to the success of biologics development.

Furthermore, the highly regulated biopharma atmosphere necessitates current good manufacturing practice (cGMP)-compliant facilities, workflows, and the utmost commitment to data integrity through the use of service-level agreements (SLAs) and laboratory information management system (LIMS)-integrated software.

A vendor who provides high-quality qPCR and dPCR products—assays, reagents, and instruments for analysis—is vital for the success of biologics development. These offerings must provide accurate and consistent data for critical decision-making in every step of the process, from discovery to commercial manufacturing.