Archive for September, 2023

In April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.

In April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.