Phase I ADC development and manufacturing: A case study
Автор: Sterling Pharma Solutions
Загружено: 2022-12-08
Просмотров: 2663
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
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