Manufacturing Expansion

Description

The client aimed to increase the capacity of their existing drug substance manufacturing facility located at their Fremont campus. The company required a design and installation for a new 12K Bioreactor at East train, 3000L Media Feed Tank, and a Centrifuge for upstream process.

IPS joined architects, engineers, and subcontractors—including electrical, plumbing, fire and life safety, concrete, and more—into one centralized building information modeling (BIM) command center located in the project field office. As the models were created, each subcontractor was able to add respective components to the project while still being in direct collaboration with other subcontractors.

Company operations continued throughout the project as IPS managed its programming, design, and construction. Key design consultants and the construction team developed the functional design brief and concept design.

The project included the construction of a new ISO-8 cell culture, the upgrade of all process piping and process utilities, and the formation of rooms in which new equipment would be installed. New TFF, packing columns, and media tanks were installed in downstream. In addition, IPS upgraded the clean-in-place (CIP), water for injection (WFI), and compressed dry air (CDA) systems. A new 50 gallon per hour acid waste neutralization system, new chemical delivery system, and new buffer and media delivery with associated piping/components were installed per GMP and FDA requirements.

IPS’s innovative safety processes led to zero incidents of significance on the project.

Project Details

LOCATION

Fremont, CA

MARKET

Biotech & Pharma

PROJECT SIZE

25,000 sf

SERVICES
  • Design Management & Peer Review
  • Project Management
KEY SYSTEMS
  • Bioreactors
  • Media Delivery
  • Upstream Process
  • Downstream Process

Company Profile

The client is one of the world’s largest pharmaceutical companies. The private company is known for its development of drug treatments related to cancer, respiratory diseases, immune system diseases, and diseases of the central nervous system.