GMP Biomanufacturing Learning Pathway

Closed Systems and CART-T Manufacturing

Entrepreneurship Bootcamp Timeline
Pre-training
Assessment, orientation,
access to preparatory material
and support (virtual)
In Lab Training
Hands-on laboratory work,
practical skills,
interactive case studies
(in person)
Post-training
Assessment and
Action Plan
(virtual)
Networking
Making new connections.
Follow-up
Program Impact
Survey
(virtual)
Total: 40h
Biomanufacturing Learning Pathway

Closed Systems & CAR-T Manufacturing GMP-Simulated Setting

This training is designed for individuals seeking to enhance their proficiency in aseptic processing techniques and gain an understanding of closed systems and CAR-T manufacturing. It offers a valuable opportunity for those whose research is focused on advanced therapies and who aspire to transition into the biomanufacturing sector, enabling them to deepen their knowledge and align with industry standards and expectations. No prior cell culture experience required.

3-day intensive Hands-on lab training Guelph, ON
Go to the BioHubNet Training Platform
To enroll
  1. 01 Apply for ENGAGE Training Credits on the BioHubNet Training Platform If you are not already enrolled in the BioHubNet ENGAGE program
  2. 02 Request to Enroll on the Training Platform under the Training Marketplace (under special programs)
Travel & accommodation support For participants travelling 2+ hours to the training site.
01 — Schedule

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
  • Biomanufacturing career exploration
  • Post-training self-assessment
02 — Learning Outcomes

What you will be able to do

GMP

GMP Requirements

Discuss GMP requirements and expectations in biomanufacturing and advanced therapy manufacturing contexts.

GDP

GDP & Data Integrity

Apply GDP using batch records and explain data integrity principles including the ALCOA+ framework.

Cleanroom

Cleanroom & Aseptic Gowning

Demonstrate cleanroom procedures, aseptic gowning, and describe cleanroom-specific job roles and career pathways.

Aseptic

Aseptic Connections

Demonstrate safe BSC use and correctly perform aseptic connections to reduce contamination risk when working with closed system platforms.

Closed Systems

Closed System Platforms

Operate closed system platforms including CliniMACS Plus, FK LOVO, and G-Rex bioreactors, and use welders and sealers.

Equipment

Equipment & Career Readiness

Use the Nucleocounter and other automated equipment; describe cleanroom job roles and assess personal skill development.

03 — Pre-Requisites

Mandatory self-paced courses before arrival

(Course access provided upon acceptance.)

Safety

Lab Safety & Biosafety

Foundation safety principles for laboratory and biological environments — mandatory before in-person training begins.

Regulatory

Introduction to GMP & Regulatory

Overview of Good Manufacturing Practice requirements and the regulatory framework governing biomanufacturing.

Documentation

Fundamentals of GDP

Core principles of Good Documentation Practice including data integrity, batch records, and ALCOA+ standards.

Technique

Aseptic Processing

Introduction to aseptic technique principles — foundational knowledge required for all in-person lab work.

Systems

Closed Systems Platforms

Introduction to closed system manufacturing platforms used in advanced therapy production environments.

CAR-T

Introduction to CAR-T Therapy

Foundational concepts of CAR-T cell therapy, including mechanisms of action and manufacturing considerations.