Training on Technology Transfer for Vaccine Manufacturing – Hybrid Course

Posted on by meetingOrganisers

5 October – 20 November 2026, Trieste, Italy

Organisers:

The Developing Countries Vaccine Manufacturers Network (DCVMN) and the International Centre for Genetic Engineering and Biotechnology (ICGEB)

In collaboration with:

Hybrid format of training delivery involving theoretical aspects of the training, which help set the foundation for Technology Transfer, will be delivered online over a span of 4-5 weeks. Zoom sessions will be organized for Virtual Instructor-led sessions & break-out group tasks. This phase of training will include Power point presentation modules/reading assignments, Case studies, Virtual interactions with Subject Matter Experts/Trainers, Knowledge checks, etc. Following successful completion of the online training, participants will move to the onsite training where they are offered immersive hands-on experience over a period of 1 week. This part of the training will allow participants to experience the learned concepts in a live GMP environment where they get to learn by doing.

The 10 attendees for this event have already been selected.

Theoretical sessions

  1. Introduction of participants and trainers, Introduction to Technology Transfer: ICGEB from R&D to industry, Technology Transfer and its challenges: definition, main features and requirements, regulatory aspects, documenting Tech Transfer
  2. Basics of IP, patents, know-how, IP and vaccines development link, IP and the global health structure – local vaccines production link (policy options, intl. instruments, pandemic agreement, etc.), Licensing and TT activities – best practices and implications
  3. Introduction to GMP regulatory aspects for vaccines (definitions, scope, key principles, guidelines)
  4. Types of vaccine processes, Bioprocess operations (upstream, downstream, QC, filling, batch release), Bioprocess guidelines- key aspects, TT case study
  5. General principles of risk analysis and Application to Tech Transfer. Commonly used methods, Risk Analysis during the Tech Transfer Project, Case
  6. Technology Transfer as a Project, Critical Success Factors in TT: Communication, Information and Documentation; Dealing with Process Risks; Transfer of Analytical Methods
  7. Deep dive on the process control strategy. Quality by design principles and process validation, Critical attributes and parameters, defining the control strategy, Implications for TT; Case studies
  8. Analytics (part 1): Analytics for biologicals. Pivotal role of QC in TT
  9. Analytics (part 2): Transferring analytical methods, Success criteria for TT: Product comparability and regulatory requirements (validation)
  10. Detailed walk through the phases of Tech Transfer. Comparison of early phase and Commercial Tech Transfer

Practical sessions

Hands-on training at ICGEB BDU laboratory in Trieste will last for 5 days, from Monday 16th November to Friday 20th November. Each day a practical aspect of the theoretical training will be uncovered. The trainees will be divided in 3 rotating groups, so each will have the chance to try hands-on activities.

Download the OnSite Training Programme here

Follow ICGEB events on social media: #ICGEBmeeting