This webinar will discuss opportunities to leverage process development and characterization knowledge across similar therapeutic technology platforms.
We will discuss the content of our recent publication: Leveraging platform and process characterization data to accelerate CGT validation and commercialization - BioPhorum Operations Group which makes recommendations for improving efficiency for CGT product development, moving faster to the validation phase.
We will cover key elements of the publication including regulatory and business considerations, What is a platform and examples, specific cell therapy considerations, phase-appropriate process development and characterization and control strategy.
Chapters:
0:00 Webinar introduction and agenda
3:49 Introducing BioPhorum
10:26 Regulatory and business considerations
14:47 What is a process platform and examples
18:43 Cell and gene therapy considerations
24:34 Cell therapy considerations
29:35 Phase appropriate process development and characterisation
44:17 Control strategy
47:42 Conclusion
Speakers:
Gina Donovan - @Regeneron
Benson Gikanga - Sangamo
Kayla Garrett - @BristolMyersSquibb
Marcos Sousa - @BayerGlobal
Негізгі бет Leveraging platform & process characterization data to accelerate CGT validation & commercialization
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