Case Study

Development and Manufacturing for Phase 1 Clinical Trial

Development and Manufacturing for Phase 1 Clinical Trial

Intravacc was in the process of developing a multivalent inactivated viral vaccine and working towards manufacturing for a phase 1 clinical trial when I joined the team as a CMC project manager.

The knowledge-intensive process of developing a vaccine candidate from concept to GMP manufacturing for use in clinical trials requires a multidisciplinary team. Mutual understanding is crucial as it facilitates better team work and collaboration spirit. Therefore, it is highly beneficial for a project manager to have previous experience in a variety of roles related to pharmaceutical manufacturing. Being able to ‘speak the language’ of the various departments proved very useful to effectively target specific concerns and needs. For me, working with people of different backgrounds, and learning from each other in turn, is one of the most gratifying aspects of the job. I feel privileged to have been part of the great team of professionals at Intravacc who supported this project.

In these early stage development projects uncertainties are often high, and inevitably events will occur that could impact the timelines, costs or quality, the three classic corners of the project management triangle. In case of such an event we proceed as follows:

  • Define potential actions to be taken
  • Assess the associated risks and potential impact
  • Decide on the path forward at the appropriate level in the organization

Performing these assessments often involves the whole multidisciplinary team, as it requires a thorough understanding of the product and production process, the internal Intravacc procedures as well as the phase-appropriate GMP requirements (refer to PDA TR56).

The project was completed successfully with the delivery of the product and associated documentation. Meanwhile, the clinical trial has been performed and positive results have been reported, indicating that the product is well tolerated and resulting in durable high titers of virus-neutralizing antibodies. Thereby an important step in the development of a safe and effective vaccine has been completed successfully, and that has been the main goal that motivated us all to work together and achieve as a team.