Training on Technology Transfer for Vaccine Manufacturing – Hybrid Course

Posted on by meetingOrganisers

3 November – 19 December 2025, Trieste, Italy

Organisers:

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

In collaboration with:

Training to be delivered in hybrid format over a span of 4-5 weeks.. Teams 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 to technology transfer: From R&D to industry; Definitions, main challenges and aspect; Formal documentation
  2. Fundamentals 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 tech transfer activities – best practices link (ie, WHO, DNDi)
  3. Introduction to GMP; Regulatory aspects for vaccines (key principles, emphasising what receiver site must meet)
  4. Types of vaccine processes, unit operations, introduction to case study process
  5. Information management and communication in TT (variety of informaton and transfer modalities, types of document)
  6. General risks, Risks in Tech Transfer: analysis and mitigation; examples
  7. Deep dive on the process. Robustness and risks; CPPs, control strategy and IPCs. Implications for TT
  8. Analytics (part 1): Parallel analytics for vaccines vs bisimilars. Pivotal role of QC in TT. Deep dive transfering analytical methods
  9. Analytics (part 2): Success criteria for Tech Transfer : Product comparability and Regulatory requirements (validation)
  10. Types of tech transfer and TT in product life cycle; walk through phases of TT; working on own case. Summary

Practical sessions

Hands-on training at ICGEB BDU laboratory in Trieste will last for 5 days, from Monday 15th December to Friday 19th December. 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 programme here

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