ATMPs Bioproduction technician

Description : This module provides an introduction to biopharmaceuticals, their specific characteristics, the main stages of their development, and the production processes : Upstream Process-USP (cell culture), Downstream Process-DSP (purification), and Fill & Finish (F&F).It is based on the regulatory frameworks governing the development of biopharmaceuticals, such as Good Manufacturing Practices (GMP), ICH guidelines, the requirements of regulatory agencies (EMA, FDA), as well as the key stages of production processes (USP, DSP, Fill & Finish).Digital modalities : Activity 1: eLearning / Activity 2 : eLearningTarget audience :Newcomers (technicians, engineers, researchers, and managers) preparing to take up a position in bioproduction or wishing to update their knowledgeStudents and teachers seeking to discover the pharmaceutical industrial environment and the challenges associated with biopharmaceutical production.Support functions (maintenance, regulatory, Quality, HSE, supply chain, Lean, PMO, data) wishing to better understand the fundamentals of bioproduction professionsEmployees in commercial functions, market access, management or partners (suppliers, subcontractors, consultants, investors) not familiar with bioproduction but wishing to better understand the ecosystem and challenges of bioproductionEvaluation procedure :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

This module covers the fundamentals of Quality Control (QC) in bioproduction, explaining its essential role in biopharmaceutical manufacturing, the types of tests performed, the documents and methods used, as well as sample and deviation management practices.It is based on Good Manufacturing Practices (GMP), quality documentation management standards, and equipment qualification guidelines. The module incorporates tools and methods such as sampling plans, validated control methods, In-Process Control (IPC) monitoring, sample traceability systems, and quality deviation analysis methods.Digital modalities : Activity 1: eLearning / Activity 2 : eLearning / Activity 3 : eLearningTarget audience :Newcomers (technicians, engineers, researchers, and managers) preparing to take up a position in bioproduction or wishing to update their knowledgeStudents and teachers seeking to discover the pharmaceutical industrial environment and the challenges associated with biopharmaceutical production.Support functions (maintenance, regulatory, Quality, HSE, supply chain, Lean, PMO, data) wishing to better understand the fundamentals of bioproduction professionsEmployees in commercial functions, market access, management or partners (suppliers, subcontractors, consultants, investors) not familiar with bioproduction but wishing to better understand the ecosystem and challenges of bioproductionEvaluation procedure :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

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).