AlfaTech Life Scienes Big Book

L I F E S C I E N C E S

OREAD

JRH BIOSCIENCES

AMGEN BUILDINGS 31 AND 42

Palo Alto, CA

Woodland, CA

Thousand Oaks, CA

Type: Laboratory & Manufacturing Size: Robotics Lab, 1,000 SF, Chemistry Lab, 10,000 SF Facilities:

Type: Manufacturing Plant, R&D Laboratory Size: 30,000 SF

Type: cGMP Manufacturing, Office Size: Building 31, 10,000 SF; Building 42, 15,000 SF

• Chemistry Lab • Robotics Lab • WFI/USP Water System

This facility produces media for cell metabolism studies and growth kinetics. It is also used for the research, development and manufacture of proprietary client products. Process piping included a WFI system with a high temperature (85°C) and ambient (25°C) loop and all necessary controls; a clean steam and plant system complete with boiler feed water pump system and blow down cooler; R.O. piping loop and system; process cooling water system with fluid cooler and chilled water heat exchanger; and process gases.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets cost-effective human therapeutics based on advances in cellular and molecular biology. A large-scale dispensing suite was added to Building 31, and Building 42 was a new cGMP raw material receiving facility. On Building 31, AlfaTech provided mechanical, electrical, plumbing, support utility design, specifications, and specialized equipment sourcing for construction of cGMP raw material dispensing suites within an existing warehouse and distribution facility. Building 42 was programmed and designed for cGMP raw material receiving and support for Building 23, a clinical trial manufacturing facility. Process engineering design included liquid caustic solution receiving, storage and transfer systems, and fresh and waste glycerol streams storage and transfer systems.

Oread is a contract provider of comprehensive contract drug development, clinical trial support, finished product manufacturing and packaging, and regulatory support for the pharmaceutical industry. AT provided full engineering services for a robotics dissolution laboratory and the installation of a new formulation chemistry facility with a cGMP WFI system (1,000- gallon storage capacity). Extensive fume hoods contain MRI lab system and sterilizer. AT worked closely with the client during the programming phase and to make sure that the robotics facility, which features a robotically-controlled vial-fill system, would be validatable. The firm also managed the preparation of mechanical, electrical, plumbing, and process designs to meet city permit deadlines.

ARADIGM Hayward, CA

Type: cGMP Pilot Manufacturing Plant Size: 20,000 SF

Aradigm is engaged in the development of novel pulmonary drug delivery systems designed to enhance the delivery and effectiveness of a number of existing and development stage drugs and reduce the need for injectable drug therapy. Clinical trial Phase III quantities of three new products for inhalation therapy will be produced at the new full-scale cGMP clinical and manufacturing facility. AlfaTech also provided services at Aradigm’s 30,000 SF production facility. The project has extensive clean rooms, including Class 100 laminar flow processing areas; a WFI generation and distribution system; and high purity gas distribution.

BRISTOL -MEYERS SQUIBB* Redwood City, CA

SLAC NATIONAL ACCELERATOR LABORATORY Palo Alto, CA

This project consisted of replacement of an aging and inefficient chilled water system serving Autoclaves in the facility’s vivarium. A key project challenge included addressing a widely variable load. The chiller was specified with three compressors to allow efficient coverage of the loads.

Type: FEH Hutches 4, 5, &6

AlfaTech provided a feasibility study for the FEH Hutches 4, 5 and 6 project to define alternate system solutions for the HVAC design. The project was in the final design phase using a single unit air handling system. The distribution system was going to occupy space that the owner wanted to reserve for future use. We provided a conceptual design study to evaluate how much space could be saved using a different system. The study included pros and cons of each system, sketches for cost estimating and peer review of existing design documents.

* Completed by AlfaTech principal during previous employment