Biopharma Group Case Study: Lyophilized Oligonucleotide Drug Product Cycle Optimization & Risk Assessment Using Quality by Design (QbD)

ABSTRACT:

A large-scale pharmaceutical company approached Biopharma Group with a newly developed oligonucleotide drug substance in a bulk Lyoguard™ tray. The aim of thus project was to develop a suitable and robust lyo cycle for the substance. However, the novel drug substance was in short supply, meaning that during cycle development, a surrogate formulation would need to be used.

Written by Biopharma Group's Sam Woodyard BSc (Hons) & Dr. Kevin R. Ward BSc (Hons) PhD FRSC, this case study outlines how the challenge was tackled along with the subsequent results and conclusions. 

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