PDA Project Execution Excellence - BioMarin Gene Therapy Facility

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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
    • Minimal CIP

    • No SIP

    • 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!

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