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
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
Daily Schedule and Pricing
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Online Live7 - 10 Apr 2025Daily Schedule at a Glance
Training course times are listed in Eastern Standard Time (ET). Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
Now Your Whole Team Can Participate in an ISPE Learning Experience
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.