Upstream and Downstream bioprocesses development and industrialization

This module introduces the fundamentals of Upstream (cell culture – USP) and Downstream (purification – DSP) process development, detailing industrial objectives, the role of CMC (Chemistry, Manufacturing, and Controls) teams, and the core principles of the Quality by Design (QbD) approach.It is based on key reference frameworks such as Quality by Design (QbD), the concept of Design Space (a defined and controlled operational range for a process), the definition and monitoring of Critical Process Parameters (CPPs) – manufacturing variables that must be controlled – and Critical Quality Attributes (CQAs) – product-related quality criteria. It also relies on the associated regulatory documentation supporting the control strategy throughout the development lifecycle.Digital modalities : Activity 1: eLearning   / Activity 2: Serious Game 2D   / Activity 3: eLearningTarget 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 TransferPersonnel 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.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 ( 80% of correct answers required).

Important information: If you choose the accessible version of a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This module offers a practical application of development methods used in cell culture (USP), through case studies focused on the production of monoclonal antibodies and CAR-T cells for cell therapy.It draws on tools and methodologies such as the Quality by Design (QbD) approach, the identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), flow cytometry (a key analytical technique for cell characterization), as well as the design of the Design Space and the associated control strategy.Digital modalities : Activity 1: eLearning / Activity 2: Serious Game 3D / Activity 3: Serious Game 2DTarget 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.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 ( 80% of correct answers required).

Important information : If you choose the accessible version of a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This module provides an in-depth exploration of purification process development methods (Downstream – DSP) through real-world case studies, focusing on the key purification steps for monoclonal antibodies and cell-based therapies.It is built upon the Quality by Design (QbD) approach, the identification and optimization of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), the modeling of the Design Space to ensure process robustness, and the analysis of specific concentration steps and their application to cell therapy products.Digital modalities : Activity 1: eLearning / Activity 2: Serious Game 2D / Activity 3: Serious Game 3D 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.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 ( 80% of correct answers required).

This module introduces the fundamental principles of technology transfer in bioproduction, outlining the key stages, stakeholder roles, and success factors involved in transferring a process from a development site to a manufacturing site.It relies on structuring tools such as GARAMP (Gap Assessment, Risk Assessment and Mitigation Plan), the preparation steps of the receiving unit, validation and comparability principles, as well as a modeling of the overall transfer process, including gap assessment, risk analysis, and the corresponding remediation plan.Digital modalities : Activity 1: eLearning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D / Activity 4: Serious Game 2DTarget 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.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 ( 80% of correct answers required).

This module presents the technological innovations that are transforming bioproduction processes, highlighting key levers for optimizing performance, quality, and industrial flexibility.It focuses on critical elements such as improvements in raw material composition, process intensification through the use of innovative chromatographic membranes, miniaturization, the integration of single-use equipment, and the digitalization of facilities to automate and enhance the reliability of production.Modalités digitales : Activité 1 : eLearning / Activité2 : eLearning  / Activité 3 : eLearningTarget 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.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 ( 80% of correct answers required).