A U.S.-based academic organization engaged DHC to provide an independent design and regulatory review of plans for a retrofit of an existing building to serve as a facility for early-stage manufacturing of HCT/Ps and cell therapies. This included an initial assessment of the available capacity of the facility to ensure that customer requirements could be met.
DHC’s design and regulatory review allowed the client to validate their current concept study facility layout, assess the expected manufacturing capacity for different products in their portfolio, and make focused changes based on DHC’s recommendation to enhance the design and help drive the project forward.
As a result, the client could be confident in their approach to redeveloping their available building in an optimized way to address the diverse needs of the product portfolio it was intended to serve.
DHC utilized its collective experience in performing facility design reviews for clients across multiple greenfield and brownfield projects in supporting this client request. Academic facilities require flexibility for multi-product manufacturing, and the team incorporated key requirements to ensure that the facility design was safe, efficient, flexible, and compliant, allowing it to support the needs of the academic organization in question while still having the capability to meet the stringency of GMP requirements in a stage-appropriate way.
In this case, an existing building was to be retrofitted as a cell therapy facility, including ISO7 and ISO8 clean rooms. Known constraints included:
An independent design review is an excellent way to pressure-test a facility concept design. For this project, DHC drew from the design and operational experience of team members who have worked in academic and commercial CGT facilities. DHC was able to provide specific feedback on a variety of issues, including:
