About the Manufacturing Advanced Therapy Medicinal Products (ATMPs) programme
Advanced Therapy Medicinal Products, or ATMPs, are innovative new therapies which use genes, cells or tissues to prevent, diagnose or treat disease and injury. These medicines often involve complex manufacturing processes, which must be carried out in line with the requirements of Good Manufacturing Practice (GMP), following carefully controlled procedures to ensure that the safety and quality of the medicinal products are maintained.
This programme will help learners to gain an initial introduction to manufacturing ATMPs. It will provide the learner with an overview of the general process flow involved in ATMP production, emphasise the importance of raw materials, and demonstrate how potential risks are controlled. A video series is also provided to explain the process steps involved in the production of viral vectors, which are used as a key component of many gene therapies.
Overarching programme learning objectives
• Understand the general process flow involved in the production of ATMPs
• Appreciate the importance of raw materials in ATMP production
• Demonstrate how potential risks are controlled during ATMP production in a GMP environment
• Explain the process steps involved in the production of viral vectors
Production of ATMPs
This module introduces the steps and processes required for producing ATMPs from the GMP manufacturer’s perspective.
It will cover the set up required prior to manufacturing ATMPs, the procurement of starting material and raw materials, and ATMP batch production requirements, including processing, monitoring, packaging and labelling, and ATMP batch release.
Learning objectives
By the end of this module, you should be able to demonstrate:
• Understanding of the general process flow of ATMP production.
• Awareness of the controls used at each stage of production: validation, documentation, training and testing.
Raw materials in ATMPs
This module defines what raw materials (RM) are and explores how critical they are to the production of ATMPs.
You will also learn how the associated risks are controlled via processes conducted according to Good Manufacturing Practice (GMP) and regulatory requirements.
Learning objectives:
By the end of this module, you should be able to explain:
• How RM are defined and why they are important in ATMP production.
• The application of a risk-based approach when introducing new RM to ATMP production, and the use of raw materials risk assessment (RMRA).
• Common terminology relating to RM in ATMPs.
Video series: production of viral vectors
This module comprises a series of videos detailing process steps involved in the production of viral vectors.
Learning objectives:
After watching this video series, you should be able to describe the key process steps involved in viral vector production.
Video 1: Seed train
Video 2: Bioreactor seeding and transfection of cells
Video 3: Harvest and clarification
Video 4 Purification (Part 1): Chromatography
Video 4 Purification (Part 2): Tangential Flow Filtration (TFF)
Video 5: Sterile filtration and final fill & finish
More information
We would value your feedback relating to any of the modules in this programme. Please complete the short feedback survey linked at the end of each module.
Primary and secondary audiences
This programme is intended for anyone wishing to gain an introduction to manufacturing ATMPs. This may include cell or molecular therapy scientists and support staff, quality control teams, quality assurance personnel, education and training leads, scientific researchers, clinical trial specialists, pharmacy professionals, and other healthcare colleagues.
Meet the team
Dr Suhair Salman
Scientist Training Lead – Gene Therapy, NHS Blood and TransplantDr Ceri Roberts
Scientific Training Manager – Cellular and Molecular Therapies, NHS Blood and Transplant
Rebekka Campbell
Programme Manager, NHSE elearning for healthcare
Jen Plested
External Project Manager, NHSE elearning for healthcare
How to access
To access this programme, you will require a Learning Hub account. If you do not have one, then you can register by selecting the Register button below. Note that if you hold a full elfh account, you can sign into the Learning Hub using your existing login credentials.
To view the Manufacturing Advanced Therapy Medicinal Products (ATMPs) programme, select the View button below. If you already have a Learning Hub account, you will also be able to login and access the resources within the programme .
Not an NHS organisation?
If you are not an NHS health or care organisation and therefore do not qualify for free access to the Learning Hub, you may be able to access the service if you have an existing OpenAthens account. Please go to Learning Hub and sign in with your existing credentials.
If you do not have an existing OpenAthens account, please contact elfh directly to check whether you may be eligible for access.
Registering large numbers of users
If you are a HR, IT or Practice Manager and would like to register and enrol large numbers of staff within your organisation for access onto the Manufacturing Advanced Therapy Medicinal Products (ATMPs) programme, please contact elfh directly.
Organisations wishing to use their own LMS
For HR departments wanting to know more about gaining access to courses using an existing Learning Management System please contact elfh directly to express interest.
More information
Please select the following link for more information on how to use the Learning Hub