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Overview
Main competencies
- Understand the fundamentals of Advanced Therapy Medicinal Products (ATMPs) - including gene therapiy, cell therapy, tissue engineering and RNA vectors - in order to identify their specific features and situate them within the European regulatory framework.
- Gain a cross-functional overview of the manufacturing and quality-control processes specific to ATMPs.
- Identify the main technological and regulatory challenges in ATMP manufacturing, to anticipate industrial and compliance constraints in a constantly evolving environment.
- Acquire essential vocabulary and concepts related to quality, GMP, and regulatory frameworks, in order to communicate effectively.
- Explore concrete examples of ATMP production through case studies and immersive scenarios, in order to connect theoretical knowledge with practical applications.
Pedagogical content
Module 1: Exploring the fundamentals of Advanced Therapy Medicinal Products (ATMPs): specificities, challenges, and applications
Module 2: Gene therapy and viral vectors: technologies and applications
Module 3: Introduction to RNA, development and applications
Module 4: Bioproduction of Cell therapy and tissue engineering medicines : use cases
Module 5: Bioproduction of gene therapy medicines : use cases
Module 6: Scaling up: overcoming challenges in ATMP bioprocessing
Module 7: Curriculum evaluation
Target audience
- Students in biology, biotechnology or pharmacy (Bachelor’s or Master’s programmes, engineering schools) who are preparing for careers in bioproduction and wish to gain an initial understanding of the specificities of ATMP manufacturing.
- Bioproduction professionals with prior experience or training in the manufacture of biological medicines who want to broaden their skills to the technologies and requirements unique to advanced therapies.
- Support-function staff (Quality Assurance, Quality Control, Regulatory Affairs or analytical laboratories) seeking a comprehensive overview of ATMP bioproduction processes and their specific features
Expertise level
Not Applicable
Prerequisites
Bachelor’s or Master’s-level background, or an engineering degree in Biology, Biochemistry, or Biotechnology, or relevant professional experience in the bioproduction industry. A solid base in cellular and molecular biology, plus a general understanding of biopharmaceutical processes, is recommended to make the most of the learning materials.
Learning modes
Blended Mode
Evaluation procedures
• 1 Evaluation at the end of each module to be able to access the next module (no limit of attempts, 80% of correct answers required)
• 1 Evaluation at the last Module to validate the Curriculum (3 attempts, 80% of correct answers required)
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
None of the activities requires an on-site training
Contact for any question
Curriculum version & date
-
Accessibility & Disability
The courses offered by Immerscio meet WCAG standards with the exception of contents in 3D, in virtual reality or augmented reality. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
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