Cyma Builders completely renovated an existing pharmaceutical production space for August Bioservices, helping to facilitate their future business goals. The client purchased the facility with the intent of developing an extensive CDMO capability located in the middle of the United States.
The initial step was to revamp the existing facility to enable manufacturing operations while the future buildings were being designed. This involved overhauling the mechanical and electrical systems, and installing new clean process utilities to support the filling process that was intended for the site.
Significant work was also done on the existing equipment mezzanine above the suites, which included removing of AHUs and installing of new ductwork. This was coordinated with other utilities and equipment to ensure clear maintenance access.
Additionally, Cyma assisted the client in arranging for a new electrical service from the public utility company, capable of supporting the increased power needs from the current renovation and future expansion projects.
This project was executed during the COVID-19 pandemic. As a result, the project suffered significant challenges related to supply chain issues which affected stainless steel piping, electrical breakers, and mechanical infrastructure.
Cyma Builders successfully completed the GMP production suites for one of our confidential clients! The purpose of this project was to expand upon the facility’s existing GMP production spaces with four new Grade B Gene Therapy suites as well as an additional freezer room.
We are proud to share that our team was not only able to accomplish the expansion successfully, but also overcome the project’s unique challenges in a seamless way.
Creating an Efficient, Workable and Easily Accesible Layout
One of Cyma’s initial tasks was to create an efficient and workable layout while also ensuring that all areas would be easily accessible from the GMP clean room’s walkable ceiling. There was an extensive effort to coordinate all trades in the ceiling and to ensure that all the ductwork, process piping, and mechanical system would be accessible from this ceiling. This was achieved utilizing BIM modeling and coordination sessions for a 10 week period at the onset of the project.
Overall, the client was very happy with the result as it is relatively easy to access anything from the walkable ceiling installed during this portion of the project!
Preventing Covid-Related Equipment Delays and Supply-Chain Disruptions
One of the main challenges of the project was dealing with supply chain disruptions and COVID related delays to the equipment. Cyma created a tracking matrix early in the job and coordinated with subs on all components to try and identify components that suffered delays as quickly as possible. Once they were identified, Cyma worked with the manufacturer to try and mitigate the delay and prevent the component from delaying the overall project.
In the end, Cyma was able to prevent any equipment related delays from affecting the overall delivery and integration of the production suites into the existing facility!
Expanding and Integrating New Infrastructure with Minimal Disruption
Another challenge on the project was actually segregating the project from the existing facility and ensuring there was no impact to existing GMP operations. This was achieved by creating a comprehensive utility shutdown matrix which allowed the facility to see when and how every project related shutdown was being performed on the project, and whether or not it would be disruptive to the facility.
The facility was then able to coordinate with their end users and Cyma to select a date that would have the least impact. During these critical shutdowns, Cyma would draft and circulate a method of procedures to further coordinate with the facilities maintenance team so they would know what tasks were being performed throughout the day of the shutdown.
This process was very helpful to both Cyma and the facility as it allowed the shutdowns to be well planned and adapt to unforeseen circumstances as needed.