Biopharmaceutical

Eichleay’s biopharmaceutical experience spans the entire manufacturing spectrum from bulk chemical synthesis through product finishing, whether in the form of orals, topicals, or injectables. We specialize in mammalian cell culture and bacterial fermentation, solid dosage and sterile liquid lyophilization and filling, biowaste inactivation, clean-in-place (CIP) and steam-in-place (SIP) cleaning systems, and process utilities, such as USP water and clean steam. We act as a partner with our clients, proactively assisting them with their process and regulatory needs from pilot-scale development through full-scale production. Our diverse portfolio includes both new facilities and renovations for some of the most recognized names in the industry.

 

BD Biosciences

Reagents Manufacturing Expansion Project – San Jose, CA

Services Included:

Architectural, Engineering, Estimating, Scheduling, Project Management, and Construction Support

Project Description:

Eichleay was involved in the 14,800 sf expansion of BD Biosciences' facilty in San Jose, CA. The objectives were to increase lab space, enhance work flows and efficiencies, increase cold room storage capacity, reduce temporary staging and storage of raw materials and work in progress (WIP), target minimum LEED certification, and deliver a fully functioning validated facility meeting user requirement within the approved corporate budget. The expansion/renovations included glass wash/vial wash areas with the replacement of outdated wash equipment; addition of a 1,600 sf, 100% redundant, validated 2-8°C cold room; consolidated freezer room; expanded and reconfigured packaging area; ISO 8 clean room (controlled, non-classified); reagents manufacturing personnel touchdown workstations; offices; mechanics office/work space; dedicated tabbers area; and dedicated room temp storage.

Genentech

Building 3 Program Management - South San Francisco, CA

Services Provided:

Architectural, Process, Process Automation, Engineering, Estimating, Scheduling, Project Management, Construction Support, Validation Support, Startup, and Commissioning Support

Project Description:

Building 3 has been integral to the development of virtually every biotherapeutic produced by Genentech. Originally constructed in 1981, this vital facility has undergone significant transformation and aging over the years necessitating a comprehensive rehabilitation plan. Eichleay was initially engaged to manage a portfolio of thrity-eight projects with a total installed cost (TIC) of approximately $250 million to extend reliable production of this facility through the year 2020. A Program structure was the best fit for the management of these technically, functionally, and spatially interrelated projects. The advantage of this approach included:

  • Single point of responsibility for coordination and oversight of work
  • Ability to recognize commonalities in scope and execute accordingly
  • Project needs were addressed globally
  • The facility knowledge possessed by few was effectively shared with all
  • High-level program reporting was utilized to assist with decision-making

Immunex (Amgen)

Process Development Facility (PDF) - Bothell, WA

Services Provided:

Architectural, Process, Process Automation, Engineering, Estimating, Scheduling, Project Management, Construction Support, and Startup

Project Description:

This project, with a total installed cost (TIC) of $60+ million, consisted of a 50,000 sf, 3-story, process development facility. Work involved unit operations for cell culture, large-scale fermentation, purification, and freeze drying. The primary use of the PDF was to supply conditioned media to develop new technology and manufacturing processes for mammalian cell derived products to support Immunex’s clinical and commercial manufacturing activities. The facility also included office, lab, and storage space required to support the new facility, as well as modifications to the existing, adjacent Microbial Facility to accommodate a new boiler.

The new facility required a major utilities yard expansion which included a 1,680 ton chilled water system, 400 hp high pressure steam/condensate system, compressed air/drier, and fuel-oil systems. A primary secondary pumping arrangement, using constant flow primary pumps and variable flow secondary pumps, was utilized. The system components were all automated through a Siemens BAS design.

 

 

 

Chiron (Novartis)

VMF and CMF Fermentation/New Purification Process Projects - Emeryville and Vacaville, CA

Services Included:

Architectural, Process, Process Automation, Engineering, Construction Support, and Startup

Project Description:

These design/build projects consisted of architectural/engineering, design, construction, and start-up of all systems for the upgrade and conversion of existing manufacturing suites for new therapeutic protein biosynthesis and purification processes at the Chiron Manufacturing Facility (CMF) in Emeryville, and the Vacaville Manufacturing Facility (VMF). The Vacaville facility was one of the first local multi-host, multi-product fermentation facilities for the production of FDA licensed biological pharmaceutical products. Eichleay’s scope of work included the design of, and design modifications to, the processing and critical services utility systems for the cGMP pharmaceutical manufacturing processes at both facilities. A new HVAC system was also included for the CMF facility.

The scope of work included: methanol, ethanol, ammonium hydroxide, acetic acid, glycerol, oxygen, nitrogen storage and delivery systems; chromatography systems; depth filtration; solvent and purification waste systems. Deliverables included: preliminary design criteria; equipment layouts; P&IDs; data sheets; SOPs; automated functional requirements; procurement; construction support; system walkdowns and as-builts; and start-up assistance.

Genentech

Trinity / Infinity / Complexity Projects - South San Francisco, CA

Services Provided:

Architectural, Process, Process Automation, Engineering, Estimating, Scheduling, Project Management, Construction Support, and Startup

Project Description:

With a total installed cost (TIC) approaching $50 million, these projects consisted of the installation of new microbial fermentation suites, modernization of existing cell culture fermentation suites, and rework of existing media preparation area within Genentech Building 3. All incorporated state-of-the-art industry and FDA standards and involved a high level of integration with existing GMP operations.

Eichleay’s scope encompassed two new CIP skids, two independent DCS systems, and modifications to critical service utility systems for the cGMP pharmaceutical manufacturing processes. Systems worked on included purified water, DI water, clean steam, instrument air, and UPS power, among others.

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