Aspen Neuroscience

Skyline Construction partnered with Aspen Neuroscience to deliver a validated cGMP manufacturing environment within an active, operational facility, supporting clinical testing and early commercial production of personalized cell therapies for neurodegenerative disease. The facility includes ISO 7 and ISO 8 cleanrooms, quality control laboratories, and supporting infrastructure engineered to meet strict regulatory and validation standards. The Skyline team approached the project with a deep understanding of cGMP compliance, recognizing that reliability, precision, and documentation were essential to Aspen’s regulatory readiness and long-term manufacturing strategy.

For Aspen Neuroscience, time-to-validation was critical. Skyline utilized a MEP design-assist delivery approach, coordinating complex systems while minimizing disruption to ongoing operations. The facility was equipped with fully validated process utilities, including CO₂, vacuum, and laboratory air systems, to maintain sterile, tightly controlled environments required for autologous cell therapy manufacturing. A new rooftop steel platform was constructed to support three 20,000 CFM rooftop air handling units, providing the airflow capacity and redundancy needed for cleanroom operations. Quality control remained the primary focus throughout both design and construction, allowing the team to complete all commissioning activities from initial start-up through Functional Performance Testing and Verification within one month. The result was an accelerated timeline that enabled Aspen to move quickly into Qualification activities and the critical system validation process. Early engagement of key stakeholders, including the third party commissioning agent, qualification and validation specialists, and the MEP, TAB, and BMS controls subcontractors, helped establish a coordinated project team aligned around Aspen’s regulatory readiness and long term operational success.