Confidential Client, Novel Vaccines Facility

About this project

This facility is intended for multi-product processing of mRNA vaccine biopharmaceutical products.

Process/support systems

The production areas included DNA Templating, mRNA Transcription,
and mRNA Purification. Fill / Finish for the mRNA product was also included within the design envelope.  Manufacturing areas for mRNA Production and cold chain Fill / Finish were provided at two different scales, Pilot Scale and Commercial manufacturing scale.

Key attributes

The feasibility design was developed as a multi-product mRNA vaccine facility, considering such design considerations for a microbial DNA template process and mRNA synthesis process, leveraging DPS’s mRNA vaccine facility design experience. Typical mRNA synthesis unit operations were included, such as linearization, transcription, purification and Lipid Nano Particle (LNP) formation and encapsulation.

The design considered the logical adjacencies between all manufacturing and supply areas and explored the potential for sharing services between the distinct manufacturing suites for a lean design. Sizing studies needed to consider future unknown products and processes bringing best current benchmarking knowledge to bear on the design. The feasibility design considered small volume mRNA final filling and lyophilization capacity as well as pandemic scale.

Given the limited regulatory guidance for mRNA vaccines in Jan., 2021, a detailed review of all current available information on the regulatory requirements of mRNA vaccines was conducted. A cGMP was then executed to address cGMP facility requirements to verify that the design concept addressed all key areas for these vaccines, such as appropriate material and personnel flows, multiproduct processing, co-location of multiple operations, closed vs open unit operations, single use processing and HVAC strategies.