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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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    ATMP Manufacturing – Cell and Gene Therapies

    This Module is designed for personnel who require an overview of the nature and function of cell and gene therapy products, their modes of manufacture (with a particular focus on autologous and allogeneic therapies), and the associated technical challenges and regulatory requirements.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins

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    SKU: BPU-1115-SPL01-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Define “Advanced Therapy Medicinal Product” (ATMP)
    • Explain the difference between ATMPs and ‘traditional’ biopharmaceutical products
    • Explain the difference between gene and cell therapies
    • Describe the biological functionality of cell therapies
    • Describe the biological functionality of gene therapies
    • Distinguish between autologous and allogeneic therapeutic approaches
    • List the main steps in manufacturing autologous therapies
    • List the main steps involved in manufacturing allogeneic therapies
    • Describe the challenges associated with ATMP manufacturing, and in general terms how these challenges might be overcome

    Learner Benefits:

    • Gain a clear understanding of Advanced Therapy Medicinal Products, including the differences between cell and gene therapies and how they differ from traditional biologics.
    • Learn about the key steps and challenges involved in the manufacturing processes of autologous and allogeneic cell therapies, enhancing your ability to navigate these cutting-edge technologies.
    • Understand the hurdles faced in the production of cell and gene therapies, including scale-up limitations, cost concerns, and contamination risks, and explore potential strategies to overcome these challenges.
    • Explore the future of ATMP manufacturing, focusing on automation and closed processing, and understand how these innovations will shape the scalability and commercial viability of cell and gene therapies.
    • Gain insight into the personalized nature of cell and gene therapies, learning how these therapies offer precise treatment options for various diseases, potentially leading to cures rather than mere symptom management.
    		 Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

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