Cell Therapy Facility Retrofit

The Ask

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.

The Impact

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’S Approach

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:

  • Limited building footprint
  • Restricted headroom in which to accommodate complex HVAC ductwork, mechanical systems, and building controls
  • Limits on allowable roof loadings for new air handling units
  • Insufficient provision of utilities, particularly electrical power, for a more energy-intensive new application

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:

  • Clean room sizing, quantities, and classifications required to meet the needs of the product portfolio.
  • Optimization of clean room operation through production segregation, equipment selection, and placement.
  • Adequacy of supporting spaces, such as materials storage, laboratories, and changing rooms, to serve the core GMP production areas
  • Management of HCT/Ps and regulatory considerations for those vs. more complex biologic cell therapy products
    (Addressing both of these needs required manufacturing segregation to optimize production.)
  • Improvement of flows to ensure GMP compliance and increase production efficiency
  • Specifying air handling system zoning and pressure regimes to assure adequate segregation between different products
  • Building infrastructure condition and required modifications
  • Project execution strategy, assessment of clean room contractors, and extent of modular construction techniques
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