be the biotech next gen.

Understand the aseptic environment and the specific behaviors

This training consists of 7 modules:

• Module 1: Impact of bioproduction on the biotherapy delivery
• Module 2: Entry in an industrial aseptic environment
• Module 3: Behaviors in an aseptic environment
• Module 4: Applicative immersive module, simulation on workstation
• Module 5: GMP (Good Manufacturing Practices) Data integrity / transversal skills
• Module 6: Lean / Digital technologies for industry 4.0
• Module 7: Final evaluation

 Identify the main steps of USP biological production

This training consists of 7 modules:

• Module 1: Impact of bioproduction on the biotherapy delivery
• Module 2: Presentation of cGMPs and industrial environment – USP
• Module 3: Behaviors for USP in cGMPs industrial environment
• Module 4: In-Process Controls (IPCs) for USP in cGMPs
• Module 5: Data integrity applied to USP in cGMPs
• Module 6: Practice USP in cGMPs
• Module 7: Final evaluation

Identify the main steps of Fill and Finish

This training consists of 11 modules:

• Module 1: Impact of bioproduction on the biotherapy delivery
• Module 2: Introduction to Fill & Finish
• Module 3: Material reception and handling
• Module 4: Thawing/Formulation & Pooling /Filtration
• Module 5: Aseptic Filling line specific conditions
• Module 6: Aseptic Filling line: Set up and filling the primary packaging
• Module 7: Sampling and control in Fill & Finish
• Module 8: Packaging, Labelling, Serialization
• Module 9: cGMPs in Fill & Finish
• Module 10: Fill & Finish – Applicative module
• Module 11: Final evaluation

Be able to conduct the DSP process in “total autonomy”

This training consists of 9 modules:

• Module 1: Impact of bioproduction on the biotherapy delivery
• Module 2: DSP Process in cGMPs
• Module 3: Behaviors in DSP in cGMPs and Industrial Environment
• Module 4: Viral Clearance
• Module 5: Equipment Cleaning in DSP
• Module 6: In-Process Controls (IPCs) for DSP in cGMPs
• Module 7: Data integrity for DSP in cGMPs
• Module 8: DSP – Applicative module
• Module 9: Final evaluation

Understand the approaches, roles, and importance of Quality Control in bioproduction to ensure the quality and safety of bioproducts.

This training consists of 7 modules:

• Module 1: Overview of Quality Control
• Module 2a: Focus on Microbiology
• Module 3a: Applicative module: microbiological tests
• Module 2b: Focus on Physico-chemistry and Immunology
• Module 3b: Applicative module: physicochemical test and immunoassay
• Module 2c: Focus on viral safety and molecular biology tests
• Module 3c: Applicative module: viral safety and molecular biology tests
• Module 4: Validation of analytical methods
• Module 5: In vitro, in vivo and ex vivo efficacy tests
• Module 6: Analytical methods: use cases
• Module 7: Final evaluation

Be able to ensure Data Integrity in any Bioproduction function.

This training consists of 6 modules:

• Module 1: Introduction to Data Integrity
• Module 2: Data Integrity: How to contribute to its implementation?
• Module 3: Computerized systems validation: a mandatory condition for Data Integrity
• Module 4: Use cases: test your knowledge in an inspection situation!
• Module 5: Data Integrity applied to product batch release
• Module 6: Final Assessment

• Module 1: Introduction to the methodology of development for cell culture (USP) and purification (DSP) processes*
• Module 2: Case study applied to the development of an Upstream process (USP)*
• Module 3: Case study applied to the development of a Downstream Process (DSP)*
• Module 4: Introduction to Technology Transfer*
• Module 5: New technological trends in bioproduction
• Module 6: Case study applied to bioprocess industrialization*
• Module 7: Case Study applied to bioproduction facility operation
• Module 8: Final Assessment

This curriculum provides the skills needed to effectively manage the supply chain, from production to distribution, including risk management and process optimization.

This training consists of 6 modules:

• Module 1: Transportation and logistics management for bioproducts
• Module 2: Transportation in a temperature-controlled environment
• Module 3: Storage and handling of bioproducts
• Module 4: Warehouse and transport qualification
• Module 5: Quality deviation management in Supply Chain
• Module 6 : Curriculum evaluation