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 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 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.
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 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.
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.
