Facility design: final design review

An EU C&GT contract manufacturing organization developing a large-scale multi-modal
manufacturing facility needed support with late-stage design reviews. This project
was extremely time-sensitive given the degree of work on the project that had already
been done before bringing Dark Horse in as a consultant.

  • The first step in this process may well sound like a final step: the design for the facility was already partially decided when DHC was brought on to do what was expected to be a final review of the planning documents and schematic drawings. An important take-home message from this case study, though, is that it is never too late to get an experienced eye on the facility design. An experienced C&GT engineer can recommend practical design improvements at most stages of development.
  • When looking at the full set of engineering diagrams, DHC’s consultants discovered that while the clean room suite design was fine from a mechanical engineering viewpoint, there were significant issues with personnel and material flows and the relative sizing of the facility. Additionally, there was insufficient storage and staging space identified in the design.
  • DHC continued to review the facility design documents, bringing to light a number of additional design improvements. One particular opportunity of note that was possible at this stage: optimizing flows of material and of waste.
  • DHC was able to provide a de-bottlenecking analysis, based on the current facility design documents, to improve the flow of materials and waste through the manufacturing suites and the supporting production areas. DHC knowledge of cell and gene therapy processes was key to developing a series of recommendations to improve production efficiency and also to reduce risks of cross-contamination and mix-ups. Relatively small adjustments to the design delivered significant operational improvements that still benefit the facility today.

Dark Horse identified a significant number of operational improvements that proved highly valuable both in timing (the design changes were able to be implemented during the construction of the facility) and in concept (if the design issues that were in place thus far hadn’t been remediated, it could have had a negative impact on the facility’s long-term operability and regulatory approval).

It is critical to note that when making significant changes like these, the degree of material difference that DHC and clients can achieve together is highly dependent on whether the client is amenable to change and to hearing alternate points of view. In this case, the client’s openness to the process made quick pivots possible without delaying the project and heralded a successful launch.

  • Manufacturing Support
  • Quant Modeling
  • Quality Systems Support

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