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Overview
Key module objectives
Describe development methods applied to the USP step
Target audience
Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.
Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.
Module Overview
Activity #1: Upstream Process steps and characteristics
• Monoclonal antibodies
• CAR-T cell for cell theraphy
Activity #2: Development methodology applied to cell therapy production in USP
• Cell therapy production
• The manipulation
• Flow cytometry
• Optimization of CCP values
Activity #3: Development methodology of a cell culture process: monoclonal antibodies case
• Quality by Design methodology
• Quality by Design methodology - QTTPs and CQAs
• Quality by Design methodology - Critical Process Parameters
• Develop the Design Space and the Control Strategy
Prerequisites
Basic scientific and technical knowledge in biology and/or biotechnology or professional experience of approximately 1 year in R&D or pharmaceutical production.
Having completed Campus Biotech Digital P7M1
Learning mode
Remote
Digital modalities
Activity 1: E Learning / Activity 2: Serious Game 3D / Activity 3: Serious Game 2D
Evaluation procedures
• A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).
• Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules.
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more.
Face to face training
Some activities on this curriculum must be done within an Immerscio Training Center. Please consult the available Immerscio Training Centers and the onsite reservation modalities HERE.Â
Contact for any question
Module Version Level & Date
Gold Version from 15/07/2024
Accessibility & Disability
The courses of this Module meet WCAG standards.
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