Leverage qPCR And dPCR To Streamline Biologics Development

With the growing demand for biologics to treat and prevent human disease, including vaccines, cell and gene therapies, mAbs, and biosimilars^1-3, manufacturers who can quickly deliver safe and effective products will be in the best position to leverage growth opportunities and capture biologics market share. However, researching, developing, and manufacturing biologics is an arduous and expensive process fraught with regulatory and supply chain challenges. It can take an average of 10 years and $2.6 billion to develop a new biologic medicine, and only 12% of candidates make it to market⁴. Others end up in “the valley of death”—the transition from laboratory to trial where candidates often fail. With such tremendous potential challenged by drastic implications for time and resources, commercial collaborators who provide advancements in efficiency, speed, quality, and regulatory support can help biologics manufacturers bridge the gap from basic research to clinical trials and manufacturing.

PCR is an essential technology in biologics development and manufacturing

Detection and quantification of nucleic acid targets are essential in comprehensive quality control (QC) testing for a wide variety of biologics performance specifications. PCR methods such as quantitative real-time PCR (qPCR) and digital PCR (dPCR) are the gold standards for sensitive, specific detection and quantification of nucleic acid targets. They have become core technologies for delivering high-quality results throughout biologics development and biomanufacturing. Working with a provider who can simplify your workflows with a comprehensive qPCR technology ecosystem can be central to maximizing the speed and efficiency of your biologics development process.