Accordingly, the objective of the guidance is to clarify the requirement for Biologics License Applications (BLAs) and Investigational New Drug Applications (INDs). Moreover, the guidelines highlight the challenges potency assay developers are facing including variability of starting materials and product...
and that it is the established strategy to establish consistent dosing in clinical studies. In addition, the vector genome titer assay per quantitative PCR (qPCR) was validated per ICH guidance to be an appropriate measurement of product strength with...
such as accuracy, precision, linearity, and specificity. However, the assessment of those parameters is specific to each product type. This is due to the interdependency of many methods and reagents commonly used in assay development.
This approach should allow multiplexed measurements of multiple mRNA constructs in a single assay. Optimizing the capture oligos for structural in addition to sequence complementarity with their target mRNA constructs would be highly valuable. It is worth noting that in a draft guidance document ...
guidance to industry on ADC development, it is recommended that a target binding assay should be incorporated into the lot release and stability testing program for mAb intermediate (unconjugated mAb) along with both target binding assay and cytotoxicity assay ...
As required by the FDA, a potency assay should reflect the mechanism of action of the cell product, be quantitative and meet requirements of accuracy, sensitivity, specificity and reproducibility [203]. Following this guidance, the research community and cell therapy companies have developed a few ...
Each dilution group requires up to 36 mice due the high variability of the assay. At 14–17 days after the immunisation, mice are challenged intracerebrally with a dose of B. pertussis (18.323) suspension prepared from a 20–24 h culture grown on charcoal agar or other suitable medium. To...
In developing regulatory approaches to whole cell cancer vaccines, the experience from the field of infectious disease vaccines should be examined for general guidance. A framework that draws heavily on the field of infectious disease vaccines is presented and suggests that at this point in the ...
we first performed a plaque formation-based entry kinetics assay and found that M1-E2M virus formed significantly more plaques as early as 5 min after nfection, confirming that it can indeed enter tumor cells faster than the parental virus (Fig.5a, b). Consistent with the finding, M1-E2M...
A more specialized review team was formed in the analytical area. This review team comprised the analytical department manager, SMEs, laboratory analysts, and associated personnel. This team reviewed all activities associated with the drug potency assay, including standard preparation, incoming sampling ...