The area of Facility Design and Engineering is the newest addition to Dark Horse’s range of core capabilities. Requests in this area often build on requests for due diligence, capacity planning, process development, technology transfer, and/or manufacturing support.
Our facility mapping team and proprietary software can model facility size requirements, equipment and instrumentation needs, and FTE by department over time under the full range of reasonable input assumptions. This enables you to consider robust planning scenarios even in environments of great uncertainty.
Common requests include facility user requirement specification, quality/GMP, regulatory reviews, and equipment specification and selection.
We offer a full range of project management offerings as well as two elements that are specifically likely to cross over to FD&E: project risk evaluation/risk management and owner’s representation. Risk evaluation and management are particularly relevant when completed by a team with deep technical expertise in CGT manufacturing. Owner’s representation also falls under this umbrella.
Two critical elements to address at early stages of facility design and buildout are that of equipment specification and selection as well as contractor and supplier audit/selection. DHC clients benefit from our overview of the entirety of the market when deciding from among a range of contractor and supplier options. Just as with CDMO selection in our Manufacturing Support offering, we provide our clients with our proprietary and quantitative RFP process, as well as our unparalleled knowledge of the cell and gene therapy landscape. The degree of support that we offer here is, as always, à la carte and based on each client’s specific needs.
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