CDMO BioPharmaceutical Manufacturing Expansion


PROJECT NAME:

CDMO BioPharmaceutical Manufacturing Expansion


LOCATION:

Durham, NC


PROJECT(S) DATA:

- 67,000 SQ. FT.

- $70MM

- Purification Suites

- Recovery Suites

- Harvest Suites

- Buffer Preparation Suites

- -70C Cold Storage

- Flammable Storage

- Weigh/Dispense Room

- Warehouse

- Utility Area


SERVICES PROVIDED:

- Detailed Design

- Project Execution Plan

- Project Schedule

- Resource Planning Cost Estimate

- Mechanical, Electrical, Process, + Process Control Design

- Project Management

BioPharmaceutical Manufacturing Expansion

Our client, a global CDMO in biopharmaceutical manufacturing of cell culture, microbial fermentation, vaccine, and gene therapies, needed to increase manufacturing capacity at the existing manufacturing facility in RTP, NC. In support of this effort, the HIPP led team provided the process and facility design for an expansion of its cell culture and microbial manufacturing trains.


The 67,000 square foot expansion of the existing facility would house four (4) purification suites, two (2) recovery suites, a harvest suite on the second level; a buffer preparation suite on the second level; raw material cold storage, a freezer room; weigh/dispense room, warehouse; and utility area. It also included the development of an area for locker rooms and a break room.


Wall-mounted utility panels and transfer panels were used to deliver services, and transfer processes, and CIP fluids. To ensure the flexibility and product segregation necessary for successful CMDO operation, HIPP designed the purification suites use roll-in equipment systems that utilize disposable single-use technology. Four new portable tanks support one of the purification suites and are cleaned via CIP station.


One of the Recovery Suites houses six fixed recovery tanks with platform access to the tops of the tanks. The fixed tanks are cleaned via CIP utilizing transfer panels. This same recovery suite included space for a centrifuge and homogenizer. New and existing utility services were provided to suites. In support of this effort, a utility capacity and impact assessment were performed. As result, clean and black utilities were upgraded along with new AHU’s and the expansion of FDBU’s process waste systems.