Phase I ADC development and manufacturing: A case study

In this speaker series, we hear from Stewart Mitchell, EVP and Site Head at our Deeside site, Stephanie Johnson, Principal Development Scientist, and Paulius Milasauskas, Senior QC Analytical Scientist, where they will be discussing a case study on phase one ADC development and manufacturing. 00:00 - Introduction 09:38 - Project introduction 10:09 - Process development approach 11:53 - Process stages 12:35 - Trial of designed process 13:10 - Process optimisation 16:33 - Scalability with UF/DF purification and filtration evaluation 17:03 - Process scalability 18:46 - Process robustness 20:06 - Additional support studies 21:28 - Analytical 22:12 - From development to GMP manufacturing 22:53 - Analytical validation 24:29 - HIC development and validation 26:52 - Cell based potency assay preliminaries 27:38 - Examples of CKA development and validation 29:42 - Batch consistency data 32:25 - Analytical data summary 32:56 - Conclusion