Plasmid DNA Vaccine Manufacturing Facility
- 240,000 SQ. FT.
- Microbial Fermentation
- Cell Harvest & Lysis
- Nucleic Acid Purification
- Buffer | Media Prep
- -80C Cold Storage
- Project Execution Plan
- Project Schedule
- Resource Planning Cost Estimate
- Mechanical, Electrical, Process and Process Control Design
- System Controls
- Project Management
BE&K, Hanbury Architects
Plasmid DNA Manufacturing Facility
Our client is a leading contract manufacturer (CMO) of DNA and RNA plasmids for use in pre-clinical research, DNA Vaccines, and gene therapies purchased 21 acres to build a new plasmid manufacturing campus in Texas.
As the first phase of the client's campus development, HIPP partnered with BE&K to deliver a 240,000 square foot greenfield plasmid manufacturing facility by executing the project as a design-build team. The new facility was designed with a processing area that includes a 1500L-scale suite, three flex suites that can support 40L-500L processes, and a specialty small-scale 10L processing suite. Additionally, the processing area contains a single RNA manufacturing suite.
All production suites are supported by central media prep and buffer prep areas. These production suites include microbial fermentation, cell harvest and lysis, and segregated plasmid nucleic acid purification. In addition, supporting utility generation and distribution systems that support manufacturing include: clean steam, plant steam, chilled water, process chilled glycol-water, CIP, WFI, purified water, process waste, vacuum, nitrogen, oxygen, compressed air, standby power, and UPS.
A 2000-gallon purified water storage tank and a 2000-gallon WFI storage tank buffer periods of high demand. cGMP compliant autoclaves provide for sterilization of media and parts and parts washers are installed to clean re-usable components. Upon future expansion, a WFI multiple-effect still or a vapor compression still can be added; the initially upsized steam generator can then accommodate the future steam demand. WFI will be used for the preparation of buffers in downstream manufacturing and as a final rinse for buffer preparation systems.
Single-use technology has been leverage throughout the process to maximize flexibility with the exception of the larger fermentation systems, buffer, and media preparation.