Closed Systems & CAR-T Manufacturing Basics
Hands-on GMP training in aseptic processing and closed-system CAR-T manufacturing, for researchers in advanced therapies moving into the biomanufacturing sector. No prior cell-culture experience required.
- 01 Register your interest Share your details so we can fast-track your BioHubNet enrolment.
- 02 Create your BioHubNet account Register on the BioHubNet Training Platform.
- 03 Apply for ENGAGE Training Credits If you are not already enrolled in the BioHubNet ENGAGE program.
- 04 Request to enrol On the Training Platform, request to enrol under the Training Marketplace (special programs).
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3-day training agenda
Day 1 — GMP, Aseptic & CAR-T Intro
- Introduction to GMP and aseptic processing
- Introduction to CAR-T therapy and manufacturing workflows
- Basic lab skills orientation
- Performing aseptic connections
Day 2 — CAR-T Expansion & Documentation
- Unit operations for CAR-T cell expansion
- Closed system platform operation
- Proper documentation practices
- GDP in practice
Day 3 — Closed System Skills & Review
- Closed system manufacturing application
- Industry case studies
- Documentation and batch record review
- Post-training self-assessment
- Biomanufacturing career exploration
What you will be able to do
GMP Requirements
Discuss GMP requirements and expectations in biomanufacturing and advanced therapy manufacturing contexts.
GDP & Data Integrity
Apply GDP using batch records and explain data integrity principles including the ALCOA+ framework.
Cleanroom & Aseptic Gowning
Demonstrate cleanroom procedures, aseptic gowning, and describe cleanroom-specific job roles and career pathways.
Aseptic Connections
Demonstrate safe BSC use and correctly perform aseptic connections to reduce contamination risk when working with closed system platforms.
Closed System Platforms
Operate closed system platforms including CliniMACS Plus, FK LOVO, and G-Rex bioreactors, and use welders and sealers.
Equipment & Career Readiness
Use the NucleoCounter and other automated equipment; describe cleanroom job roles and assess personal skill development.
Mandatory self-paced courses before arrival
(Course access provided upon acceptance.)
Lab Safety & Biosafety
Foundation safety principles for laboratory and biological environments, mandatory before in-person training begins.
Introduction to GMP & Regulatory
Overview of Good Manufacturing Practice requirements and the regulatory framework governing biomanufacturing.
Fundamentals of GDP
Core principles of Good Documentation Practice including data integrity, batch records, and ALCOA+ standards.
Aseptic Processing
Introduction to aseptic technique principles, foundational knowledge required for all in-person lab work.
Fundamentals of Cellular Immunotherapies
Introduction to closed system manufacturing platforms used in advanced therapy production environments.
Introduction to CAR-T Therapy
Foundational concepts of CAR-T cell therapy, including mechanisms of action and manufacturing considerations.
Take the next step in advanced therapies manufacturing.
Request to enrol through the BioHubNet Training Platform. Eligible trainees pay nothing out-of-pocket with ENGAGE Training Credits.