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Understanding Cell and Gene Therapy Manufacturing

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This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

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Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

The cell and gene therapy sector (or ATMPs) continues to grow with an increasing number of therapies progressing through clinical development. As a result, manufacturing output and personnel continues to rise. However, cell therapy manufacturing and gene therapy manufacturing are complex and differ significantly to other industries. Professionals must refine their knowledge and skills to stay up to date in this fast-moving industry.

 

This training course provides manufacturing/production personal with the skill and knowledge to perform with confidence. During the course you will examine manufacturing techniques and process for both cell and gene therapies. You will review the EMA and FDA guidelines for working with cells specifically looking at aseptic GMP working environments. You will examine the importance of cryogenics and a freeze/thaw protocol on product quality. Finally, you will understand common logistical and supply chain issues and strategies to overcome them.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • Examine manufacturing techniques and processes for cell therapies, gene-modified cell therapies and gene therapies.
  • Review and examine various CGT products including; induced pluripotent stem cells (iPSCs), CAR T and haematopoietic stem cells.
  • Learn the importance of aseptic working in a GMP environment to maintain compliance
  • Examine in depth cell therapy manufacturing so you understand key processes and techniques
  • Analyse gene therapy manufacturing so you understand key processes and techniques
  • Understand the regulatory requirements for working with genetically modified cells to ensure compliance with EU and US
  • Appreciate the challenges of supply change, logistics and patient location on patient delivery
  • Understand the importance of developing an effective freeze/thaw protocol to minimise potency and save money

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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

This course is aimed at professionals who work in CGT production/manufacturing. It has been designed for people transitioning from pharmaceutical/biotech manufacturing into cell and gene therapy manufacturing.

 

These include: Process Scientists | Process Development Personnel | Production Personnel/Technicians | Analytical Scientists | Process Engineers | Quality Professionals | CMC Regulatory Affairs.

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