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11 reviews for
An Introduction to Cell and Gene Therapies: A Beginner’s Guide
11 September 2025 | Short Online Course
Original price was: £350.00.£280.00Current price is: £280.00.
1-day live online training |Â Understand the basics of cell and gene therapies to support you in your role.
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)
Course Outline
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
11 September 2025
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
Module 1: Introduction to the CGT industry
- Incentives for the development of these advanced therapeutics
- What is a cell therapy?
- What is a gene therapy?
- Diversity of CAR T cell generations (1st to 4th and beyond)
- Product development overview
- Examine the fundamental differences between biopharmaceuticals and CGTs
Module 2: Examine the science of CGTs
This module will provide you with an overview of how biopharmaceuticals are made and how their quality is ensured. Â This will then be brought into perspective to the novel CGTs and highlight some fundamental differences in the approach to development and manufacture these unique products.
- Examine the biopharmaceutical life cycle
- Approaches to ensure clinical safety and efficacy
- How does that differ from Cell and Gene Therapies?
- Different CGTs may require different approaches for development
Session 2
120 mins | 1:00 PM UK
Module 3: The CGT manufacturing process
Now you know the science behind CGTs, this module will examine the manufacturing process from start to finish for selected products such as cell therapy and CAR T cells.
- Examine key terminology within manufacturing
- Autologous versus allogenic products
- What is a viral vector and why are they important in CGT?
- Selecting the right viral vector for delivery
- Analysis of the CGT for patient safety
Module 4: Examine major challenges during CGT development and manufacturing
In this module you will examine some of the major challenges faced by companies when developing CGT product such as manufacturing facilities, regulatory problems and bioanalytical issues.
- The need for specific equipment for production
- Overcoming regulatory hurdles
- Bioanalytical challenges of CGTs
Dr. Melody Janssen is an expert in bioanalysis and immunogenicity testing of biopharmaceuticals with in-depth experience as a project manager, trainer and senior expert in biotech/CGT companies. She has worked on numerous biopharmaceutical products and is an expert on all areas of biopharmaceutical development and manufacturing.
Dr. Janssen has extensive experience of the regulatory frameworks (EMA, FDA etc.) for biopharmaceutical development/manufacturing. Ultimately Melody is aware of the many challenges biopharmaceutical companies face when developing a therapeutic product.
She is frequently invited to speak at conferences on immunogenicity and bioanalytical testing, where she also leads conference specific workshops and seminars. She has shared her knowledge through trainings for over 10 years focusing on assay validation for bioanalytical, potency and immunogenicity assays.
For the last years, Dr. Janssen has been working as a freelancer for projects including non-clinical and clinical immunogenicity assessment, leading various late pre-clinical candidates to FIH, production of vaccines and biologics and teaching bioanalytical method validation workshops.
Her educational background is in infectious diseases and immunology, with a PhD in pharmaceutical sciences investigating the effect of protein aggregates on immunogenicity.
This course is specifically designed for professionals who are not technical experts but wish to have a high level understanding of cell and gene therapies. It is also ideal for technical professionals who are new to cell and gene therapies. It will provide you with comprehensive overview of the sector to support you in your job.
Sectors and job roles this course is most suited for include:
- Technical professionals starting out in cell and gene therapies who require a comprehensive overview
- All supporting functions such as marketing, finance and IT
- Investment Professionals
- Recruitment Professionals
- Legal and IP Professionals
Pfizer Ltd (verified owner) –
n/a
Pharmaplan (verified owner) –
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Benchling (verified owner) –
It was a really good overview and now I can tailor my attention and focus on the gene and cell therapy processes that I want to dive into.
Roche Products –
n/a
Health Canada (verified owner) –
n/a
Gilead (verified owner) –
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AmplifyBio –
n/a
Danish Medicines Agency (verified owner) –
n/a
Halmed (Hungarian Agency) (verified owner) –
Presented in a very interesting manner, all relevant details provided.
Eppendorf (verified owner) –
In my role as Regulatory Affairs Manager, I needed to gain a better understanding of the CGT field as well as challenges faced by our CGT customers to determine expectations for Quality and Regulatory requirements related to equipment. The course presented vital information and I was pleasantly surprised at the volume of information as well as the ability of the presenter to communicate complex scientific information in an understandable manner for a non-scientist.
SFDA (verified owner) –
N/A