Advanced Therapy Manufacturing

In partnership with the Andalusian Network for the Design & Translation of Advanced Therapies (ANd&tAT), ISCT is proud to offer this online Educational Program on Advanced Therapy Manufacturing free-of-charge for ISCT members.

The program aims to foster the training of professionals in the fundamentals of ATMP regulation and the specific knowledge necessary for the development of medicinal products for cell therapy, gene therapy, and tissue engineering.

Course Topics

  1. Cell and Gene Therapy Manufacturing Methods
  2. Quality Assurance
  3. Product Development Pathways
  4. GMP Compliance
  5. Investigational Medicinal Product Dossier (IMPD) Writing
  6. Biosafety

Program Brochure

Program Format

  • 6 self-serve online courses on the And&tAT e-learning platform
  • A certificate of completion is attainable for each individual course. ISCT members may choose to complete as many courses as they desire.


  • ISCT membership required for enrolment
  • Accessible free-of-charge
  • Ensure you are signed into your ISCT member account to access the ANd&tAT e-learning platform.  Link and enrolment key provided under Access Instructions

Access Instructions 

First time users will be required to create an account on the ANd&tAT e-learning platform.

Course Descriptions:

Course 1

Provides the theoretical basis to understand conditions for ATMP production, with an emphasis on the importance of culture media, equipment, facility design, etc. Basic knowledge of cell identity, sterility, virus safety and detection of replicant competent virus will be discussed among quality control in manufacturing cell and gene therapy products.

Course 2

Provides the knowledge of guaranteeing that all the processes are organized and carried out with the objective of ensuring that medicinal products are of the quality required for their intended use (clinical grade). 

Course 3

Helps students to develop their abilities and show a roadmap to bring basic laboratory results to the bedside. It reviews intellectual property and industry right management in advanced therapies adopting a worldwide perspective. Finally, some speculation is provided on next generation ATMPs (iPSC? transdifferentiated cells? targeted mutation replacement?) and future perspectives in advanced therapies will be summarized so that the student may foresee alternatives that might impact their product development strategy in the not-so-distant future.

Course 4

Describes Good Manufacturing Practice (GMP) as applied to ATMPs. While the generic GMP regulations is common knowledge that is easily accessible to anyone, we expect this section to explain this to the students in a very clear manner by making use of specific examples. 

Course 5

Summarizes the structure of an investigational medicinal product dossier (IMPD). The IMPD is required to start a clinical trial. During this course, it is described as applied to ATMPs using specific examples not only related to this purpose but also to the difficulties usually encountered by independent researchers.

Course 6

Examines biosafety issues related to donor selection, cell and tissue manipulation as considered specifically under transplant and pharmaceutical legislation. Regulatory requirements for gene therapy products (GMO) and pharmacovigilance are also discussed.