Bioprocess of innovative therapy drugs or “ ATMPs ”

This module introduces Advanced Therapy Medicinal Products (ATMPs), their modalities, regulatory framework, development stages, and production, using real-life examples from the field.It is based on the regulatory frameworks governing ATMPs (GMP, ICH Q9, pharmacovigilance, marketing authorization), as well as on fundamental concepts of preclinical and clinical development, illustrated through concrete examples of innovative therapies.Digital modalities : Activity 1 : eLearning/ Activity 2 : Serious Game 2D  / Activity 3 : Serious Game 2D /  Activity 4 : Serious Game 2DTarget audience : Bioproduction employees with prior experience or training in the manufacturing of biological medicines, wishing to expand their skills to the technologies and requirements specific to Advanced Therapy Medicinal Products (ATMPs).Students in biology, biotechnology, or pharmacy (Bachelor’s or Master’s level, or engineering schools) preparing for a career in bioproduction and looking to gain an initial understanding of the specificities of ATMPs manufacturing.Support function personnel (Quality Assurance, Quality Control, Regulatory Affairs, or Analytical Laboratories) wishing to acquire the fundamentals of ATMPs bioproduction processes and their specific features.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 explores the fundamentals of gene therapy and the technologies involved in viral vector production, presenting their biological principles, clinical applications, and the challenges of bioproduction and quality control.It covers various genome modification strategies (deletion, insertion, substitution), gene-editing tools (CRISPR-Cas9, TALE, ZFN), types of viral vectors (lentiviral, retroviral, adenoviral, AAV) and non-viral vectors (plasmids, lipid nanoparticles), bioproduction processes, specific quality controls (purity, sterility, biological activity), as well as clinical case studies illustrating therapeutic applications.Digital modalities : Activity 1 : eLearning/ Activity 2 : Serious Game 2D  / Activity 3 : Serious Game 2DTarget audience : Bioproduction employees with prior experience or training in the manufacturing of biological medicines, wishing to expand their skills to the technologies and requirements specific to Advanced Therapy Medicinal Products (ATMPs).Students in biology, biotechnology, or pharmacy (Bachelor’s or Master’s level, or engineering schools) preparing for a career in bioproduction and looking to gain an initial understanding of the specificities of ATMPs manufacturing.Support function personnel (Quality Assurance, Quality Control, Regulatory Affairs, or Analytical Laboratories) wishing to acquire the fundamentals of ATMPs bioproduction processes and their specific features.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 describes RNA classes, gene-editing tools and processes for producing non-viral vectors for RNA transfer in gene therapy.It is based on the main classes of RNA (mRNA, siRNA, miRNA, lncRNA), silencing techniques, exon skipping, and mRNA-based vaccination, genome editing tools (CRISPR-Cas9, ZFN, TALE, base editing), RNA synthesis processes (chemical, biochemical, biological), non-viral vectors (lipid nanoparticles – LNP), quality control requirements (identity, purity, sterility), as well as concrete clinical case studies.Digital modalities : Activity 1 : eLearning/ Activity 2 : Serious Game 3D  / Activity 3 : Serious Game 2DTarget audience : Bioproduction employees with prior experience or training in the manufacturing of biological medicines, wishing to expand their skills to the technologies and requirements specific to Advanced Therapy Medicinal Products (ATMPs).Students in biology, biotechnology, or pharmacy (Bachelor’s or Master’s level, or engineering schools) preparing for a career in bioproduction and looking to gain an initial understanding of the specificities of ATMPs manufacturing.Support function personnel (Quality Assurance, Quality Control, Regulatory Affairs, or Analytical Laboratories) wishing to acquire the fundamentals of ATMPs bioproduction processes and their specific features.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 covers bioprocesses applied to cell therapy and tissue engineering through practical case studies, highlighting cell sources, culture processes, aseptic production requirements, and associated quality controls.It covers the types of cell sampling, production processes (transduction, expansion, differentiation), matrices used in tissue engineering (natural or synthetic), growth factors, as well as critical controls (identity, sterility, functionality) and requirements for cell traceability and preservation.Digital modalities : Activity 1:  eLearning / Activity 2: Serious Game 2D  / Activity 3: Serious Game 3DTarget audience : Bioproduction employees with prior experience or training in the manufacturing of biological medicines, wishing to expand their skills to the technologies and requirements specific to Advanced Therapy Medicinal Products (ATMPs).Students in biology, biotechnology, or pharmacy (Bachelor’s or Master’s level, or engineering schools) preparing for a career in bioproduction and looking to gain an initial understanding of the specificities of ATMPs manufacturing.Support function personnel (Quality Assurance, Quality Control, Regulatory Affairs, or Analytical Laboratories) wishing to acquire the fundamentals of ATMPs bioproduction processes and their specific features.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 covers the practical manufacturing of gene therapy medicines, including viral and non-viral vectors, as well as ex vivo processes.It is based on therapeutic strategies involving mRNA delivered via lipid nanoparticles (LNP), in vitro transcription and encapsulation processes, viral vector production (adenovirus, lentivirus), cell transduction and expansion steps, formulation requirements (buffers, excipients, filling), as well as specific quality controls (identity, purity, sterility, functionality).Digital modalities : Activity 1:  eLearning / Activity 2: Serious Game 3D  / Activity 3: Serious Game 2DTarget audience : Bioproduction employees with prior experience or training in the manufacturing of biological medicines, wishing to expand their skills to the technologies and requirements specific to Advanced Therapy Medicinal Products (ATMPs).Students in biology, biotechnology, or pharmacy (Bachelor’s or Master’s level, or engineering schools) preparing for a career in bioproduction and looking to gain an initial understanding of the specificities of ATMPs manufacturing.Support function personnel (Quality Assurance, Quality Control, Regulatory Affairs, or Analytical Laboratories) wishing to acquire the fundamentals of ATMPs bioproduction processes and their specific features.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).