Quality Control in bioproduction

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

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 explores potential sources of microbiological contamination, methods of prevention and detection, as well as the lifecycle of microbiological samples from their collection to their analysis in the laboratory. It provides the knowledge needed to identify and control contaminants in order to ensure the safety and quality of pharmaceutical products.The module lists and describes the different categories of contaminating microorganisms, their biological characteristics, and their impacts on processes and biopharmaceuticals. Potential sources of contamination—such as raw materials, air, surfaces, personnel, and equipment—are presented, along with the associated routine microbiological tests used to measure bioburden, sterility, and the detection of mycoplasma and endotoxins. Environmental monitoring methods (air, water, surfaces, personnel) in accordance with EU GMP Annex 1 are explained, as well as the references and standards applicable to biocontamination control (GMP, ISO 14644, NF EN 17141).Digital modalities: Activity 1:  eLearning / Activity 2: eLearning  / Activity 3:  Virtual RealityTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 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 physicochemical and immunological analyses necessary to ensure the quality of therapeutic proteins. It introduces the sources of impurities, their potential impacts on products and patients, and the methods of detecting and quantifying impurities. Practical case studies will provide opportunities to apply the knowledge acquired.It is based on the five fundamental analytical pillars applied to therapeutic proteins (identity, purity, impurities, activity, quantity), the methods associated with each pillar (HP-SEC, cIEF, etc.), techniques for detecting and quantifying impurities at different stages of production (mass spectrometry, liquid chromatography, etc.), as well as best practices for controlling raw materials and starting materials, in connection with contamination prevention and traceability in a GMP environment.Digital modalities: Activity 1:  eLearning / Activity 2: eLearning  / Activity 3:  Virtual RealityTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)

This module provides an in-depth understanding of the complementary approaches required to ensure viral safety of bioproducts. It introduces molecular biology methods, material selection, viral testing, and viral clearance steps. It is based on the three pillars of viral safety (raw material selection, virological controls, and viral clearance steps), the criteria for selecting raw materials based on their origin and risk profile, virological testing conducted at various stages of the process, detection methods (PCR and RT-PCR), as well as the mechanisms of viral removal and inactivation, primarily applicable to recombinant products.Digital modalities: Activity 1:  eLearning / Activity 2: eLearning  / Activity 3:  Serious Game 2DTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)

This module covers sampling processes in production areas, quality control laboratory operations, and the analysis of unexpected results and deviations. It introduces best practices to ensure sample quality, laboratory testing methods, and approaches for managing deviations and implementing effective corrective and preventive actions (CAPA).It is based on the Contamination Control Strategy (CCS), microbiological controls associated with key stages of the manufacturing process (sterility tests, bioburden, endotoxins), simulated aseptic filling procedures (Media Fill Test), environmental monitoring plans (surface, air, personnel), identity and purity tests of bacterial strains, as well as examples of corrective actions in response to contaminant detection.Digital modalities: Activity 1:  eLearning / Activity 2: eLearning  / Activity 3:  Serious Game 2DTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)