AlfaTech Big Book

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

OREAD

AMGEN BUILDINGS 31 AND 42

*JANSSEN PHARMACEUTICALS

Palo Alto, CA

Thousand Oaks, CA

Vacaville, CA

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

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

Numerous upgrade and expansion projects were executed throughout all aspects of the facility including labs, manufacturing process and HVAC systems and building utility upgrades, manufacturing clean room projects, site infrastructure and utilities and administrative tenant improvements. Projects included: • Multi-year plantwide HVAC system renovation and replacement to modernize the plant’s clean room HVAC systems and to meet cGMP requirements. • Process Dust Collection System collecting hazardous dust produced pharmaceutical product manufacturing. • Manufacturing Suite projects to accommodate new products and processes including suite workflow layout, utility system design (electrical, O2, AOF, N2, chilled water, clean steam, etc.), waste streams, Architectural improvements. • Regenerative Thermal Oxidizer • Manufacturing Equipment Safety Upgrades to meet J&J Corporate safety standards • Raw Materials Warehousing and Lab • 1MW Solar Farm Condition Assessment and Upgrades • Manufacturing Washrooms • QC Labs

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

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.

*BRISTOL -MEYERS SQUIBB Redwood City, 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.

• Code Studies • Data Center

* Completed by AlfaTech principal during previous employment