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HIV vaccine process development, scale up, technology transfer (TT) and site readiness

I have been involved in developing an Adeno based HIV vaccine drug substance production process and was a downstream processing subject matter expert during the TT of this pilot scale process from Leiden to Springhouse. In a joint collaboration between Leiden and Springhouse R&D facilities, the process has been scaled up to commercial scale. I participated in a team involved in design of equipment and facility of a newly build commercial production plant at Janssen Biologics Leiden: the vaccine launch facility. After the construction and equipment qualification, I managed a team responsible for the TT from Springhouse and Leiden R&D facilities, to this vaccine launch facility. This technology transfer included upstream, downstream, medium and buffer preparation and has taken place according to internal standards including, training of the receiving unit, person in plant support, etc.. I had the opportunity to obtain guidance from experts in the field like C. Goochee.

The part of the project related to readiness of the production site comprised conducting and evaluating engineering batches, the introduction and qualification of many new (raw) materials, embedding the facility in the governance and systems of the production site (QA, SAP, EHS etc.), performance qualifications.