ATMP Manufacturing

ATMP Manufacturing Training Course (T64)

Overview

This course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide. This course stays at the facility level and establishes guiding principles from the GPG that should be considered during these emerging and rapidly evolving times. This course is written from the perspective of an allogeneic or autologous cellular therapy or gene-modified cellular therapy

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What You Will Learn

• Defining ATMPs
• Regulatory Considerations
• Manufacturing Definition
• Unit Operations
• Manufacturing Controls
• Segregation
• Facility Considerations
• Supply Chain Management
• Technology Transfer
• Scale-up/Scale-out

Resources and Activities

• Pre-Course Work Materials
• Interactive Exercises
• Learning Assessments
• Guide: ATMPs - Autologous Cell Therapy

Course Modules

• Introduction to ATMPs
• The Science behind ATMPs
• Regulatory aspects/QRM of ATMP Manufacturing, focus on Cell Therapies
• Supply Chan considerations for ATMPS with focus on Cell Therapies
• Manufacturing Considerations for ATMPs; focus on Autologous Cell Therapies
• Facility Considerations
• Tech Transfer, Scale-up, and Supply Chain considerations

Who Should Attend

• A/E Consultants in Facility Design
• Project/Manufacturing Engineering resources engaged in ATMP project execution
• Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management having assigned ATMP-focused roles/responsibilities
• Personnel who need an in-depth understanding of the potential risks around ATMP manufacturing
• Service organizations, suppliers, and vendors who serve pharmaceutical industry Clients focused on ATMP manufacturing
• Academic Institutions engaged in ATMP development/manufacturing
• Vendors and Suppliers of equipment/systems focused on the global ATMP “launch”

Additional Course Details

Learning Objectives:

• Background and impact of personalized medicine
• Defining the baseline platforms of ATMPs and how they differ from current biomanufacturing operations
  • Cell Therapies
  • Gene Therapies
• Understanding of regulatory requirements
• Understanding of the fundamentals around manufacturing process definition
  • Process Descriptions
  • Process Attributes
  • Supply Chain Characteristics
  • Equipment Considerations
  • Scale
  • Closed Systems & Single-use
  • Patient-specific therapies
• Identification of facility design drivers to support the manufacturing process
• Impact of scale-up and tech transfer on ATMP manufacturing
• Identification of the unique characteristics of the ATMP Supply Chain and risks
• Definitions of key process control parameters

Community of Practice (COP)

This training course will be of particular interest to:

• Existing members of the Biotechnology CoP
• Future members of the new Advanced Therapy Medicinal Products (ATMPs) CoP
• Existing and future members of the ISPE Process/Product Development COP
• Members focused on manufacturing risk assessment/mitigation
• Quality assurance and quality control specialists, validation specialists