Gene Therapy Manufacturing Facility Design + CM

Catalent Cell & Gene Therapy, is a global contract development and manufacturing organization for clinical through commercial supply. The gene therapy market has experienced considerable growth in the last few years and expectations are that it will continue.  The increased client demand for its expertise in gene therapy and vaccine manufacturing allowed for the expansion of Catalent’s commercial facility in Harmans, Maryland (near Baltimore).

The new building provided Catalent Cell & Gene Therapy with a unique opportunity to quickly design, construct and qualify a new Current Good Manufacturing Practice (CGMP) commercial manufacturing facility while also providing the necessary space to grow CGMP warehouse, administrative, laboratory and support functions.

In response to its clients’ needs, Catalent Cell & Gene Therapy required this fully flexible manufacturing facility and associated spaces to be constructed in less than 12 months from project initiation. Working closely with CRB, the team was able to design and construct a multiproduct, multiprocess facility predicated on maximum flexibility and adaptability while prioritizing segregation between manufacturing suites to maintain a low risk of any cross-contamination and protecting client confidentiality. This partnership amongst all the team members successfully executed integrated project delivery with an aggressive timeline to improve the speed to market.