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United Therapeutics DDOMAL Project
Projects

Neuroblastoma Therapy Production Facility, DDOMAL

United Therapeutics, Silver Spring, Maryland

DDOMAL is a statement building that illustrates UT’s commitment to think outside of the box and try radical new approaches to R&D for long term positive social impact. The criticality of the project for patients and the limited time frame allowed designers to flex their creative muscles and truly be innovative in their project execution.

This partnered design/build project for a new commercial-scale GMP manufacturing facility was fast-tracked by United Therapeutics to produce monoclonal antibody-based orphan drug treatments for pediatric neuroblastoma.

Balancing the challenge of space constraints and the desire to stay within the city of Silver Spring, the project team developed a novel design to maximize space and build up, instead of out. The building was designed around the process inside and needed to go far below grade where municipal utilities were located.

The team coordinated rerouting of these utilities, shoring sub-grade walls below the water table and closing adjacent roads to complete the construction. As a result of the space constraints, the facility was built modularly. Lay-down space was located outside city limits and brought to the location piece by piece.

The building consists of four main floors and two interstitial floors. The lowest level (cellar floor) will support the main utilities and fixed process equipment for the project as well as house the locker rooms and restrooms.

The cellar provides access to all floors of the building via two stair towers and a freight elevator. The interstitial floors will be used to support the manufacturing equipment and building MEP equipment located on the first, second and third floors. Additionally, the first, second and third floors will be CGMP spaces accommodating the processing suites and processing support functions.

The new ground-up facility manufactures using bioprocessing technology at 2000L production scale. The initial request is that the program includes the following elements:

  • Inoculum prep (vial break to T-flask expansion in shaker incubator)
  • Media preparation
  • Buffer preparation
  • Upstream processing (seed reactor through harvest depth filtration)
  • Pre-viral downstream processing (viral inactivation through affinity and AEX chromatography to viral filtration)
  • Post-viral downstream processing (UF to bulk fill into bags) 
  • Just-in-time consumables storage and receiving area
  • Weigh and dispense area
  • Sampling area
  • Process and black utilities plant 

This monument to life sciences in an urban environment was built with the commitment to overcome limitations of the site. An excellent example of project management, teamwork and handling an aggressive timeline to answer the urgent need for Unituxin won this project the 2020 ISPE FOYA for Social Impact and ENR MidAtlantic's Best Projects award in Manufacturing. This building has been certified as LEED Platinum.

Visit ISPE's website to see the this project and rest of the winners: https://ispe.org/facility-year-awards/winners/2020/social-impact

Visit ENR MidAtlantic's website for more information: https://www.enr.com/blogs/11-mid-atlantic-monitor/post/49775-enr-midatlantic-names-2020-best-projects

Client Name: United Therapeutics
Region: AmericasCountry: United StatesOffice: Blue Bell, PA, Germantown, MD
Services: Design - Basis of Design (BOD), Design - Conceptual (GMP and non-GMP), Process, Process Architecture, Mechanical/HVAC, Electrical, PipingIndustries: Biotechnology & Biomanufacturing, Pharmaceutical, Science & Technology, Therapeutic ProteinsFacility Types: Research & Development, Manufacturing
Size: 35,000sfAwards: 2020 ISPE Facility of the Year Award, Social Impact; ENR MidAtlantic Best Projects: Manufacturing.
Client Name: United Therapeutics
Region: AmericasCountry: United StatesOffice: Blue Bell, PA, Germantown, MD
Services: Design - Basis of Design (BOD), Design - Conceptual (GMP and non-GMP), Process, Process Architecture, Mechanical/HVAC, Electrical, PipingIndustries: Biotechnology & Biomanufacturing, Pharmaceutical, Science & Technology, Therapeutic ProteinsFacility Types: Research & Development, Manufacturing
Size: 35,000sfAwards: 2020 ISPE Facility of the Year Award, Social Impact; ENR MidAtlantic Best Projects: Manufacturing.

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