(SOURCE: CRB Group)
ONEsolution Delivery of a State-of-the-art Manufacturing Facility for cGMP Biologics
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The article originally appeared on CRB’s website.
Read the original article here: https://www.crbgroup.com/projects/kbi-biopharma-onesolution-manufacturing-facility
KBI Biopharma, Inc., a contract development and manufacturing organization (CDMO), engaged CRB to design and build a $150 million commercial manufacturing facility using our ONEsolution™ method.
With eight locations across the US and Europe, the global organization provides process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. The new Patriot Park Commercial Manufacturing Facility located in Durham, North Carolina, supports the manufacturing of mammalian-based products in late-phase clinical and commercial programs. The facility incorporates Manufacturing 4.0 principles through the design and integration of advanced technologies.
Existing facility retrofit vs new shell fit-out
When CRB and KBI first started collaborating in late 2019, during what CRB calls the “business alignment case phase” to determine exactly what the facility needed to be, from the number of employees needed to its process development needs, the plan was to retrofit an existing KBI facility. However, as the team discussed conditions of satisfaction, we quickly realized that a retrofit was not going to meet their values or optimum business case needs.
The less expensive, and more flexible option was to lease a new shell that had site and building permits in hand but had not broken ground. This allowed KBI to customize it to their exact needs with no compromises to their processes. CRB worked with KBI leadership and a local developer to find the perfect location for their new space in Patriot Park, just a few miles from their mammalian drug development facility.
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