Hands-on GMP workshop

One of CellCAN's Network Affiliate, the Centre d'Excellence en Thérapie Cellulaire (CETC) in Montreal, was the host of a hands-on GMP workshop from October 14th to 16th, 2018. This exclusive training, organized by CellCAN in partnership with C3i, gave the opportunity to learn the essentials of GMP requirements from experts illustrated by several experiences from actual clinical trials.

Thanks to a mixture of lectures and hands-on training, participants were able to transform knowledge into action and had access to the cleanrooms of the CETC for a highly enlightening learning experience. Take a peek at the workshop's curriculum below. 

Introduction

The number of good manufacturing practice (GMP) facilities is growing in Canada with the rapid progressions in cell therapy. This has created a need for well-trained highly qualified personnel (HQP), as working under GMP conditions and requirements for GMP manipulations are regulated and quite different than in standard research laboratories. In this course the attendees will learn the essentials of GMP requirements from experts illustrated by several experiences from actual clinical trials. The workshop is a mixture of lectures and hands-on training. Participants will actually perform manipulations according to the GMP standards. Moreover, attendees will have the chance to experience the workflow in a GMP facility and learn how a GMP cell therapy facility is organized. 

Who Should Attend

This workshop on Good Manufacturing Practice is designed for cell biologists, technologists, research scientists, process engineers and trainees (and other end users) who are working or plan to work in areas associated with the manufacturing of cell therapies, or want to expand their knowledge on advancing cell therapy projects towards the clinic. The outcome from this unique workshop will be the transfer of advanced knowledge creating a foundation of GMP-based know-how for the next generation of HQP.

Workshop Learning Objectives

  • Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) and associated standards
  • Health Canada Food & Drug Regulations: Part C Drugs, Div. 1, Div. 1A Establishment Licence, Div. 2 Good Manufacturing Practices, Div. 4 Schedule D Drugs (Biologics), Div. 5 Drugs for Clinical Trials Involving Human Subjects
  • International Harmonization guidelines
  • Foundation for the Accreditation of Cellular Therapy (FACT)
  • ISO levels and measurement requirements – airflow
  • Organizational set-up – clean rooms, product and waste flow, shipment (cold chain transport)
  • Training of personnel on protocols
  • Standard Operating Procedures (SOP) & Batch Records
  • Product certificate of analysis, release criteria and documentation
  • Data and sample storage
  • Single- versus multi-site requirements
  • Minimally manipulated versus more than minimally manipulated cells
  • Project Progression 

Workshop Agenda

Day One – 13:00 – 16:00, Sunday

  • Introduction to the GMP facility
    • Requirements, standards of clean rooms
    • Visit of the facility 

Day Two – 8:00 -16:00, Monday

  • Equipment required to maintain GMP standards
  • Regulations regarding cell therapy projects
  • Training of personnel
  • Defining release criteria
  • Examples of cell therapy projects at the CETC
  • Typical progression of projects

Day Three – 8:00 – 16:00, Tuesday

Hands-on course. Participants will be working in groups of three.

  • Cell production
    • Cell culture transfers
    • Automated Ficoll cell separation (Sepax)
    • Cryopreservation
    • Evaluation and sterility testing
  • Quality Control
    • Flow cytometry
    • Microscopy
    • Sterility analysis using BacTalert
  • Debriefing and questions
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