Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Module 1

FREE to Attend

60 mins

Understanding cell & gene therapies and the differences between them

• Important definitions between cell therapy, gene-modified cell therapy and gene therapy
• Ex vivo vs in vivo gene therapy
• Autologous vs allogeneic products
• Example products, including NK cells, Stem Cells, CAR T
• Brief overview of the manufacturing process in cell vs gene therapies

Module 2

120 mins

Deep dive into cell therapy manufacturing processes

This session will provide you with a detailed overview of the manufacturing processes of cell therapies. You will be able to easily understand key processes.

• Understand that autologous cell therapy includes receiving starting material obtained via apheresis from the patient and allogeneic from a donor. Understand that ex vivo culture is required, with details on how this is achieved, before patient infusion.
• Understand that gene-modified cell therapies have an additional modification step, where gene transfer or gene editing changes the cell phenotype (such as with CAR T) before infusion.
• Understand that genetic modification can be achieved via means other than viral vector technology: naked DNA, CRISPR/CAS9 and electroporation

Module 3

120 mins

Deep dive into gene therapy manufacturing

This session will provide you with a detailed overview of the manufacturing processes of gene therapies. Once completed you will understand the key processes.

• Understand that Gene therapy is designed to genetically modify cells to compensate for abnormal genes or to make a beneficial protein
• Understand how the corrective gene is maintained
• Understand the rational to use different methods to genetically modify cells including viral and non-viral vectors
• Ex vivo vs in vivo gene therapy
• Germ line vs somatic

Module 4

120 mins

Understanding best practice for working with cells

In this session you will understand the practices which need to be adopted when working with genetically modified cell lines to produce cell and gene therapies.

• Guidelines on good manufacturing
• Practice EU vs US regulations
• Cell collection, culture, modification, storage, infusion
• Air quality – understanding that contamination can occur via airborne particles and aspects such as air filtration and particle counting needs to be measured
• Quality control and drug product release
• Identity, Viability, Microbiological Sterility
• Sterility testing of cell therapy products

Module 5

120 mins

The Importance of cryogenics

In this session you will learn that some raw materials and final products need to be cryogenically frozen for storage and transportation. You will learn about important consideration for this process.

• Definitions
• Why is it important – inadequate freezing can result in a direct loss of potency which costs money and compromises patient safety
• Products frozen at -130 degrees
• Selecting the best cryoprotective agent and rate-controlled freezing protocol
• GMP management of a cold space – logistics and distribution

Module 6

120 mins

Logistical considerations

In this session you will understand how complexities of supply chain and logistics impact therapeutic delivery. You will learn that patient locations and timeframes have on delivery.

• Supply chain considerations: cell lines, plasmids, tissue culture materials – where are they coming from, how is quality ensured?
• Transportation and storage – where is the modification taking place in relation to the patient.
• Should there be a satellite site for modification steps?
• Quality tests times may exceed the shelf life of the drug products which may be released at risk – what are the ethical and regulatory guidelines concerning this
• The importance of working with hospital staff to ensure efficiency.

TBC