The challenge
In a time where treatments and vaccines were being developed under Operation Warp Speed (OWS), it was critical to work with an experienced engineering, procurement, construction management and validation (EPCMV) partner who understood how to appropriately fast-track these critical projects.
The solution
The scope of the project involved the renovation of an existing building and providing facilities for clinical and pre-clinical mRNA manufacturing technology to meet FDA and EMEA standards. We completed schematic design, design development, construction documents, construction administration, and early CQV documents. We also supported the firm with process piping walkdowns.
The impact
The design of the new facility addresses s objectives of having a single, fully integrated early development engine capable of manufacturing an expanding pipeline of drug candidates in a highly adaptable platform. The digital production environment can now enable high throughput with a robust and diverse set of products. The enterprise and process control systems are integrated in a manner that enables flexibility and rapid new product introduction in a highly-automated landscape.
209,000 sq. ft.
clinical manufacturing facility
Achieved 18-month
project schedule to complete first GMP batch
The challenge
In a time where treatments and vaccines were being developed under Operation Warp Speed (OWS), it was critical to work with an experienced engineering, procurement, construction management and validation (EPCMV) partner who understood how to appropriately fast-track these critical projects.
Fortunately, the tremendous ongoing efforts by hundreds of life sciences companies were supported by the architecture, engineering, and construction (A/E/C) industry, which is applying expedited EPCMV approach to help deliver licensed facilities more quickly.
We worked with a leader in the pharmaceutical and biotechnology space to help them increase performance and production of COVID-19 treatment and vaccines by supporting the completion of a new clinical manufacturing facility.
The solution
The scope of the project involved the renovation of an existing building and providing facilities for clinical and pre-clinical mRNA manufacturing technology to meet FDA and EMEA standards. We completed schematic design, design development, construction documents, construction administration, and early CQV documents. We also supported the firm with process piping walkdowns.
We took on a proactive approach by getting a head start on the conceptual designs to develop early cost estimates, determine available schedule options and critical path activities, and identify the technology that needed to be deployed first. By beginning conceptual designs early, we were able to reduce risk and helped gain months on our planning timeline.
From the beginning of the project it was very clear that the client was totally focused on promoting game changing technology across a very wide clinical program, capable of changing the way treatments and curative medicines would be developed and manufactured forever. The extent of the commitment to developing a flexible, agile facility of the future was beyond anything in the current market at that time and was a key motivating factor to all team members on the journey to beat cancer. It wasn’t until the pandemic that the realization of how flexible and agile a facility we designed truly was, as the client was able to pivot and develop a vaccine to respond based on the technology platform that was implemented.
The impact
The design of the new facility addresses s objectives of having a single, fully integrated early development engine capable of manufacturing an expanding pipeline of drug candidates in a highly adaptable platform.
The digital production environment can now enable high throughput with a robust and diverse set of products. The enterprise and process control systems are integrated in a manner that enables flexibility and rapid new product introduction in a highly-automated landscape.
Digital technology is integrated throughout the site and includes integration of the enterprise resource planning system with electronic production records, process control systems, the data historian, and laboratory information management system. This digital platform streamlines product manufacturing, testing, and release. It also enables robust data management to support development activities and process characterization.
With the client now confidently adopting new technologies such as robotics, automation, artificial intelligence, and cloud-based platforms, they’re able to exceed both industry standards and stakeholder expectations.
