Standard Guide for Minimizing the Impact of Stability Testing on Batch Yield of Low Yield Biopharmaceutical Products

Importancia y uso:

5.1 Stability studies are important in biopharmaceutical product development and they are required by regulatory agencies. The “stability tax” is particularly significant for products whose processes have low yields. Stability studies and sample use plans must be optimized to allow for proper execution of both stability and clinical aspects of product development.

5.2 Appendix X1 provides an example of stability sample optimization for a mock rAAV process. The example shows that product savings of up to 17 % of a drug substance (DS) batch and 44 % of a drug product (DP) batch relative to the baseline protocol may be possible.

Subcomité:

E55.12

Volúmen:

14.01

Palabras clave:

biopharmaceutical; optimization; sample volume; stability; yield;