Logan Kelley and Carl Albertson presented on a recent Gene Therapy facility build-out at BioMarin. This project had received an award for project execution from ISPE and is also a current contender for the 2018 Project of the Year award. The project excellence presentation was very interesting and it was amazing to see the completed 54-week timeline, as well as their internal observations of what went well and what could have been improved upon.
Some key takeaways from the presentation:
The client ensured that the complete project schedule was created and maintained (i.e. included all C&Q activities, not just up to the point of the GC handover to the client).
Some educated decisions and guesses were made without 100% of information known, such as the best placement of equipment process utilities, etc.
This fast-paced project required ongoing team energy and motivation, which was fueled by keeping in mind the positive benefits of the new product that would be produced at this facility.
Maximizing the use of disposable systems, in comparison to a stainless steel and hard-piped facility, resulted in a shorted a project timeline. Some reasons for this are listed below:
- Minimal parts washing and autoclaving cycles to develop and qualify
Purchase of commercial off the shelf systems (COTS) minimizes need for extended FATS, and custom written IOQs
It was a pleasure to sponsor this event and learn more about how members of our industry are striving for excellence in all that they do. A big thanks to PDA for hosting this wonderful evening and looking forward to seeing more of you at future events!