AlfaTech Life Scienes Big Book

SOLUTIONS FOR THE LIFE SCIENCES

INNOVATIVE IDEAS | INTEGRATED SOLUTIONS | SUSTAINABLE PARTNERS

01

OVERVIEW / Profile & Services

02

Market & Relevant Projects

PPS #19228

OVERVIEW 01

Profile & Services

P R O F I L E

AlfaTech has built its reputation on providing the most innovative and sustainable engineering solutions from master planning through construction administration. Our presence is not only in the continental United States, but internationally as well. Our clients include numerous large multi-national firms, many ongoing clients we’ve been serving for years. We strive to provide intelligent and innovative strategies starting with project inception, in order to provide maximum benefit to our clients during the entire development process whether it be new high-rise projects, mixed use projects or revitalization of existing communities. Our team provides the most appropriate engineering design solutions which are highly efficient and cost effective, and promotes the greatest possible return on investment for our clients. Our goal is to build the most dynamic relationships, be attentive to the needs of our clients and partners, and be true team players. With this mindset, we’ve built a stellar list of clients.

AbbVie Biotherapeutics

Alza

eBay

UNITED STATES San Francisco San Jose Los Angeles Atlanta

INTERNATIONAL Europe Asia Middle East Latin America Africa

Additional Resources Through Our Sister Companies

60+ locations | 27+ countries | 4,000+ staff

S E R V I C E S

MECHANICAL ENGINEERING DESIGN HVAC

ARCHITECTURAL LIGHTING DESIGN Lighting and Lighting Controls Lighting Calculations

COMMISSIONING | ENERGY SOLUTIONS Early Quantifiable Energy Study Incentives

Heating Systems Water and Gas Cooling Systems / Chilled Water Dehumidification Systems Contamination Sensitive Areas Industrial Hygiene Systems Low Tolerance Temp Control Title 24 Analysis and Design Heat Recovery Systems Central Utility Plants Air Handlers HVAC System Controls PLC Programming Fire Protection and Plumbing

Customized ROI Calculations Sustainable Lighting Design

Energy Star® Assessments Retro-commissioning (RCx) Monitoring Brand Continuous Commissioning (MBCCx) ASHRAE Level 1, 2 and 3 Energy Audits Measurement and Verification (M&V) of installed projects Energy Modeling Net Zero Energy Budgeting HVAC/Chilled Water Plant Optimization

Energy Savings Analysis Custom Lighting Fixtures Design for finishes, fabrics and light sources

TECHNOLOGY DESIGN Low Voltage Design Security Design Audio Visual Design Wireless Design & Modeling

PROCESS Industrial Waste Collection Acid Neutralization Bio-Kill Waste System Process Waste Containment Ultra pure De-ionized Water Systems USP Water WFI Specialty Chemicals Chemical Storage

Strategic Consulting Project Management Relocation & Migration

ELECTRICAL ENGINEERING DESIGN Power Systems

Emergency & Standby Power Lighting and Lighting Controls Security Systems 24 / 7 Power Systems (UPS) Power Monitoring Systems Toxic Gas Monitoring Graphic Control and Alarm Panels Grounding and Bonding

SUSTAINABILITY Sustainability Planning (Organizational and Infrastructural) LEED / Green Building Consulting Masterplanning Life Cycle Cost Assessment Occupant Wellness and Comfort

Lab and Special Gas Systems Ultra High Purity Gas Piping

Bulk & Specialty Gases Toxic Materials Handling Code Compliance Process Distribution Piping Process Cooling Water Medical Gas Medical Vacuum Waste Anesthetic Gas Disposal system (WAGD)

Energy Management Energy Conservation Fire Alarm Systems Public Address Systems Plug Loads Control

Façade Engineering CFD / Wind Studies Wind Studies Thermal Stratification Studies Energy Concept Studies

Dental Vacuum System Dental Water System

S E R V I C E S

GREEN BUILDING

SUSTAINABILITY

PLANNING

LIFE

PROCESS ENGINEERING DESIGN

OF A BUILDING

MECHANICAL ENGINEERING DESIGN

ELECTRICAL ENGINEERING DESIGN

ARCHITECTURAL LIGHTING

TECHNOLOGY

RETRO COMMISSIONING

COMMISSIONING / ENERGY SOLUTIONS

CONSTRUCT I ON

OCCUPANCY

END OF USE

DES I GN

L I F E S C I E N C E T E AM L E A D S

TERRY STELTER Sen ior Principal, Life Sciences

HARV VIJ Principal Process Engineer

Harv has over 20 years of experience in design, commissioning, project engineering / management and validation support of manufacturing systems and cGMP facilities design and construction. His experience consists of projects in pharmaceutical manufacturing, R&D laboratories, biotechnology and educational facilities. Harv is experienced in cGMP facility design, commissioning, critical utilities systems such as WFI, clean steam, CIP and process gases.

Terry Stelter is the Senior Principal-in-Charge of the AlfaTech Consulting Engineer’s Life Sciences business unit. He has over 20 years of experience with multi-disciplined teams for many high-profile clients in the Life Sciences industry. Terry’s Life Science experience includes projects in R&D laboratories, pharmaceutical manufacturing, commercial buildings for life sciences clients, and campus infrastructure. He is well versed in cGMP requirements and design and construction standards required for FDA compliance. He has extensive experience in the pharmaceutical, biotech and medical device industries, with notable clients such as Genentech, Bayer, Johnson and Johnson, and Novartis.

KEN KAHRS, PE, LEED AP Mechan ica l Engineer

MARK FISHER, PE, LEED AP Lead E lectrical Engineer

Ken has over 25 years of experience in HVAC, process piping and plumbing design. Mechanical design experience includes a wide range of projects for pharmaceutical and biotechnology laboratories, vivariums, health care facilities, clean rooms, data centers, research labs, site utility piping, central plant design, and campus utility infrastructures.

Mark is experienced in the design and construction of commercial offices, mission critical, clean rooms, manufacturing, educational and others. He is well versed in the preparation of programming and master plans, feasibility studies, building evaluations, and coordination studies. As well as all types of lighting and electrical design including low/medium voltage power distribution, lighting, fire alarm, security and low voltage technology systems. Mark has been lead engineer on numerous LEED certified and LEED Platinum projects.

AlfaTech has assembled a highly qualified team of professionals to serve our Life Science clients. The staff shown on these pages comprise our lead professionals overseeing staff in their respective disciplines. Each lead individual brings extensive experience providing planning, analysis, design and construction administration services required to execute projects in the challenging and exacting environments of Life Sciences facilities whether they be laboratories, GMP manufacturing, utility systems, office space or campus infrastructure. With our in-house staff and strategic partners, AlfaTech provides solutions throughout the entire life cycle of our clients’ facilities including site selection, planning and design, commissioning, validation and startup. Our experts support ongoing operations including FDA Inspection preparation and recommissioning. Our team is dedicated to providing the highest quality services available in our industry.

Technical Leadership is supported by over 140 employees in the AlfaTech design group.

L I F E S C I E N C E T E AM L E A D S

JAY CHOKSHI Principa l, Mechan ica l Engineer

WAYMOND HO Process Design Engineer

Jay has extensive experience as a Principal-in-Charge and as project manager in design of major HVAC engineering efforts for Life Sciences, Mission Critical, Commercial, and Healthcare projects. His background includes design for laboratories, clean rooms, vivariums, pilot plants and commercial manufacturing. With much of his experience being in fast-track design/build, he works closely with architects and contractors to ensure an efficient, cost effective solution. In addition, Jay manages multi-discipline engineering design teams for large scale projects. An expert in energy efficient design, he specializes in post-occupancy commissioning.

Waymond has over 40 years of experience in a wide range of process / utility engineering design and project management projects in the biotech, pharmaceutical, automotive, electronics/semiconductor and aerospace industries. Design experience includes operation of high technology manufacturing, industrial, laboratory and educational facilities, clean rooms, RO/DI water systems, high purity gas and chemical delivery systems. He is knowledgeable on energy efficient design, feasibility studies, ROI analysis, project estimating, scale-up, final design, material and equipment specifications, as well as validation process for the food and drug industries, FDA / USDA and cGMP regulations and procedures .

SHERIF MESSIHA, AIA, NCARB Life Science Lab Planner

BILL HARRISON, RA Project Manager

Sherif has over 32 years extensive portfolio in designing Life Science Projects and Site Master Planning worldwide in the Pharmaceutical, Biotech, Nutritional, Food and Beverage, and Cosmetic industries. He has developed a six-step interview process that, captures, creates food for thought, documents, gets the client involved, and prepares the documents from Conceptual to signed Detail Design stage.

Bill is an experienced project and client manager with over twenty years of experience managing multi-discipline design projects and observing construction for multiple advanced technology, biopharmaceutical and hospital clients. His extensive experience includes architectural, mechanical, process piping, plumbing design, as well as management and coordination of multidiscipline design teams from conceptual design through construction close-out. He has served as project manager, project architect and designer on a variety of projects. His services include master planning, space planning, contract documents, construction administration and quality control.

02 MARKET

& Relevant Projects

LIFE SCIENCES

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

AlfaTech offers a full range of professional engineering services from concept creation to commissioning and validation, including feasibility studies, condition assessments, planning, design, program management and construction period services. Our experienced professionals are expert in cGMP and GLP compliance and understand the difficult decisions Life Science facility owners make every day when choosing between economy and function. Our team has the experience and capabilities to address projects throughout our clients’ facilities from labs to manufacturing or corporate office and campus infrastructure. We have the capacity, experience and business structure that allows us to support a wide range of projects from the small consulting scope to ground-up campus projects.

This combination of resources and skills provides a strong value proposition, predicated on innovative solutions and disciplined cost, quality and schedule management.

STRATEGIC PARTNER SERVICES Architectural Planning and Design Structural Engineering Process Controls Validation Site Civil Engineering Turnkey Clean Process Utilities

SERVICES Process Engineering Lab Planning and Design Master Planning Mechanical Engineering Electrical Engineering Facility Condition Assessment

Site Selection Sustainability

FDA and EU Compliance Consulting Commissioning and Energy Solutions

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

LABORATORIES Clinical GLP QC BSL 1, 2 and 3 Flexible Labs

GENERAL BUILDING / CAMPUS SYSTEMS AND SPACES Electrical Distribution (480V to Low Voltage Systems) Site Electrical Distribution Backup Generation UPS HVAC Technology Systems (Communication, AV, Security, WIFI) Lighting and Lighting Controls BMS/EMS Tank Farms and Utility Yards

PLANT AIR SYSTEMS Scrubbers Clean Rooms Room Pressure Profiles and Cascade HEPA Filtration Exhaust Hoods and Dust Collection Explosion Relief

cGMP COMPLIANT MANUFACTURING FACILITIES Pilot Plant Clean Rooms

PERMITTING AND REGULATORY COMPLIANCE FDA Inspection Readiness Support Air Permitting Support Code Analysis and Building Code Occupancy Issues Building Permit Administration and Support WASTE WATER AND HAZARDOUS WASTE TREATMENT Waste Treatment Process Design Recycling Systems Heavy Metals Removal and Neutralization Reverse Osmosis and Ultra Filtration Solids Removal Systems Biohazard Treatment and Detoxification Incineration

Truck Docks Warehouse Data Centers Corporate Office

Commercial Manufacturing Process Batching and Campaigning Areas Blending and Mixing Rooms Fill and Finish Wash Room Packaging and Labeling Production Equipment Specification Production Equipment Utility Hookup Isolation Technology Containment Facilities Gowning Rooms Warehouse and Material Handling

PROCESS AND BUILDING UTILITY SYSTEMS WFI

CIP and SIP Clean Steam Process Chilled Water RO/DI CDA Specialty Gases Lab Gases Solvent Systems Central Plants

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

BUCK INSTITUTE STEM CELL RESEARCH LAB

Novato ,CA

Type: Lab, Animal Handling facility Size: 60,000 SF

AlfaTech provided project management, as well as mechanical and electrical engineering services for this project. Systems include the addition of a ground coupled geothermal system, which provides heating and cooling to the new addition and the existing 60,000 SF lab facility. Geothermal ground water at 61 degrees will be used to condition lab fume hood make up air, freeing up 300 tons of cooling from the existing central plant. The additional chilled water tonnage will be used for the new addition. The new geothermal system will provide all cooling & heating for the existing & new 60,000 ft2 lab building, and “no additional tonnage” will be required for the existing central plant. The geothermal system will also save 7,500.000 gallons of water a year from being evaporated via the existing (now decommissioned) cooling towers.

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

ABBVIE BIOTHERAPEUTICS (FORMERLY ABBOTT)

Redwood City, CA

Type: Data Center, Campus, Laboratory, Pilot Plant Size: 400,000 SF with central Data Center

AlfaTech was selected as a turnkey firm to design and build Abbott's 400,000 SF new headquarters campus. The facility now houses an Abbott spinoff company called AbbVie. This project includes a 4,000 SF raised floor data center, tenant improvement of offices, along with laboratory facilities, and vivarium (animal care facility). A pilot plant (cell culture and purification) was built on the first floor along with new laboratory facilities, offices, and service yard. AlfaTech was fully responsibly for programming, design and construction of this state-of-the-art campus for which the budget and schedule was guaranteed as a part of our highly successful single-source project delivery method.

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

STANFORD UNIVERSITY CLARK CENTER R&D FACILITY

Palo Alto, CA

Type: R&D Laboratory Size: 200,000 SF

This 200,000 SF project is a multi-story building on the Stanford University campus dedicated to biotechnology research and development. The firm was responsible for the design of the HVAC, fume exhaust, building automation, and peer review of the plumbing/process piping systems.

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

ALZA

Various Bay Area Sites

Type: Laboratories, cGMP Manufacturing, Vivarium, Office, Pilot Plant Size: 1, 000,000+ SF

Sampling of Projects:

Vacaville cGMP Facilities: • Original Manufacturing Building • Aqueous Tablet Coater • Fluid Bed Dryer • High Shear Granulation • Pharmaceutical Processing Area • Tablet Coating Process • Methylene Chloride Distribution Mountain View Facilities: • Buildings M2 & M3 Biocenter • M1 Pilot Plant & Research Center

Palo Alto Facility: • Buildings M8 & M9 • Underground Tanks

AlfaTech and AlfaTech team members have provided design services for various Bay Area sites listed above.

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

GENENTECH

South San Francisco, CA

Type: Office , Laboratory, cGMP Manufacturing Size: 100,000 SF

AlfaTech provided a new $1.1 million, 2-story facility for animal research labs and support areas. The mechanical design features double-duct, double-fan, constant volume mixing boxes with HEPA filtration. In addition, the firm provided full facility design services for Genentech’s Vacaville campus under a Master Services Agreement. This work encompasses office space, laboratory and cGMP manufacturing.

GENENTECH* South San Francisco, CA

Type: R&D Laboratory

Small Portfolio Program ($10 mm and less construction value). Supported Genentech’s Small Project Portfolio program for the pharmaceutical research and manufacturing company’s South San Francisco Campus. Provided Architecture and Engineering planning, design and construction support for a wide variety of facility projects including research labs, GMP cold room upgrades, building condition assessment and upgrades, waste stream compliance and utility systems. Utility systems include electrical infrastructure, steam, compressed air, exhaust, fire suppression, domestic water, sanitary sewer, chilled water and plant gases

* Completed by AlfaTech principal during previous employment

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

MASSBIOLOGICS VIRAL VECTORS* Fall River, MA

Type : Bioprocessing Facility

The MassBiologics South Coast Facility in Fall River, MA is a bioprocessing facility located on a four-acre green field site within the newly developed 300 acre Fall River Executive Park near State Route 24.

The building contains administration offices, conference rooms, and staff support areas. The facility included a mechanical mezzanine structure above a section of the bioprocess area to house process utilities and HVAC units. The basement level area contains liquid waste collection and treatment systems, as well as a plant steam system and boiler plant. Use of gene therapy vectors using AAV approach.

* Completed by AlfaTech principal during previous employment

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

MASSBIOLOGICS cGMP CULTIVATION SUITE* Boston, MA

Type : cGMP Manufacturing Size : 2,700 SF

MassBiologics constructed and commissioned a new 2,700 sf cGMP manufacturing area within the Mattapan II Facility (MTP2) for cultivation of toxins used to manufacture Tetanus and Diphtheria Toxoids Adsorbed (Td) vaccine. Since the toxin, Clostridium tetani is a spore-forming organism, the area design, controls and monitoring are based on FDA industry guidance document: “Manufacturing Biological Intermediates and Biologic Substances using Spore-Forming Microorganism” dated September 2007. The Culture Area is located in the basement of the MTP2 building along with process utilities and storage areas. Additional offices, IT server data center and a mechanical area containing HVAC is located on the second floor. The new Culture Area contains an IND Cell Bank room for the manufacture of mammalian and non-Td GMP cell banks.

Engineered Systems Designed Include

• Clean room design • Single pass HVAC system • Spore and No-spore Laboratory spaces • RO/DI system • WFI system • Water Reclamation • BL-2 Labs

* Completed by AlfaTech principal during previous employment

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

GILEAD SCIENCES

Foster City, CA

Type: Office, Laboratory, cGMP Manufacturing, Pilot Plant, Campus Size: 500,000 SF

AlfaTech provided MEP and telecommunications design for Gilead’s campus consisting of 16 buildings including administrative and private offices, pharmaceutical development processing suites, pilot plants and cGMP therapeutic manufacturing / production areas.

New Systems include: • Process Vacuum System • Nitrogen System • Process Compressed Air System • Cooling System • Dust Collection System

• Exhaust System • System Controls

• Air Shower System • USP Water System • RO/DI Water System • Domestic Water System • N2 Gas System

• Process Waste System • Building Service System • Emergency Power System • Distribution System • Class II Hazardous Locations (Granulation and Drying, Milling and Blending, Tablet Coating, Tablet Compression, Weigh Room)

The firm also provided MEP engineering design services for Gilead’s 35,000 SF pilot plant on the Foster City campus as part of a previous project.

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

GENENCOR

Palo Alto, CA

Type: Offices, R&D Laboratory, Pilot Plant Size: 77,500+ SF

This International Technology Center facility combines basic research, pilot plant development, and robotics under one roof. This cGMP project required complete equipment layout, installation design for a pre-manufactured fermentation skid, tank design, and design of three automated 1,500-liter recovery vessels.

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

BIOMARIN PHARMACEUTICAL GALLI EAST EXPANSION (BGEX)

Novato, CA

Type: cGMP Manufacturing Size: 20,000 SF

AlfaTech’s services included management oversight of facilities operations for the manufacturing plant during facility validation. Scope included management of standard operating procedures, spare parts, training of new systems, turnover of systems and facility from contractor to BioMarin and plant engineering services.

BIOMARIN PHARMACEUTICAL* 95 Digital East Laboratory Build-out, Novato, CA

Type : R&D Laboratory

Engineering Design of HVAC, process systems and piping including process cooling water (PCW), clean in place (CIP) systems, deionized water (DI), water for injection (WFI), clean dry air (CDA) and plumbing for build out of shell space to new R&D laboratories.

BIOMARIN PHARMACEUTICAL* Novato, CA

BioMarin executed a utility yard expansion to accommodate additional capacity for lab and manufacturing facilities. The project included specification and conceptual design for addition of a 400-ton chiller to an existing 1000-ton system and 7,000 lb steam boiler to an existing 125 psig plant steam system. The scope also included design of a new enclosed two-story plant utility yard structure with architectural finishes to match the existing building. Challenges included design of new distribution piping to connect new equipment to the existing chilled water and plant steam systems, accommodation of existing equipment including emergency generator and water treatment systems as well as the facility’s loading dock.

* Completed by AlfaTech principal during previous employment

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

SOKA UNIVERSITY OF AMERICA

Aliso Viejo, CA

Type : Campus Expansion, Labs Size : 200,000 SF

AlfaTech is providing mechanical, electrical, and plumbing design services for this university campus expansion project located near Irvine, CA. The Engineering / Science / Lab / Admin Building will be 4 stories and approximately 100,000 SF with classrooms, administrative offices, and wet and dry labs. The Resident Housing facility will be 4 stories and comprised of approximately 75 to 80 rooms.

Both proposed projects will be designed to accommodate a LEED Gold Building Certification, and an exterior architectural design pallet that will respect the current design features, landscaping and cultural aspects of the campus.

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

BAYER HEALTHCARE

*BAYER HEALTHCARE B14 HVAC Upgrade, Berkeley, CA

M C GUFF PHARMACEUTICAL*

Berkeley, CA

Compounding & Filling (503a &503b) Facility Master Plan Santa Anna, CA

Type: Manufacturing Plant Size: 40,000 SF

The goal of this project was to improve occupant comfort and the energy profile of the nearly 100-year-old Building B14 which was being used by research team for critical future drug products. Project challenges included very limited capital available and architectural constraints of a building constructed before HVAC systems were invented such as low ceilings, and no interstitial space. The project team the Target Costing methodology to prioritize the design features in order to stay within budget as a result of early collaboration between the design team, the contractor, the site facility team and the end user. Project features included replacement of existing air handlers, replacement of windows to reduce heat gain and careful HVAC zoning within the space. The project required detailed implementation planning as the project was installed over several budget years.

Responsible for Master Planning, Options Development, Programming, and Conceptual Design for two separate facilities, 503a &503b. On a Greenfield 80,000 SF & 60,000 SF

AlfaTech was selected to perform design construction management services for the replacement and upgrade of the B55 WFI system. The state-of-the- art replacement WFI system consisted of a single HWFI loop with multiple POU heat exchangers. WFI temperatures at the POUs were controlled using HMI panels. The firm scope of work included: interviews with the users to determine WFI consumption; production of complete WFI design-built and demo bid packages; procurement of owner-furnished components; selection of a design-built contractor; and management of the final design and construction effort.

XOMA THERAPEUTICS Berkeley, CA

Type: cGMP Warehouse , Manufacturing, Research, Pilot Plant Size: 8,000 SF and 10,000 SF

For the Pilot Plant, the project includes conversion of the X-5 pilot plant to a combination of manufacturing and research. Modifications were made to the existing facility, bringing it to current ADA standards, and generally “state-of- the-art” status. For the cGMP warehouse facility, the firm provided full design services which entailed the renovation of an existing facility along with validation support and construction management. The warehouse concept entailed the renovation of an existing facility along with validation support.

THE JACKSON LABORATORY WEST West Sacramento, CA

BAYER HEALTHCARE* Various Projects, Berkeley, CA

Type: R&D Laboratory, Vivarium Size: 91,000 SF

This project involved the relocation of Bayer’s BioAnalytics lab necessitated by the planned demolition of the aging building housing the original lab. The project included redesign of the lab layout to improve workflow and accommodate lab analytical equipment and sample storage freezers, design of gas utilities, wet utilities and waste, electrical power and lighting, cabinetry and architectural finishes.

AlfaTech provided MEP design services for interior improvements to an existing tilt-up concrete warehouse, as well as an expansion into an existing facility. The new use of this space includes West Coast regional offices, animal vivarium, wash/sterilization facilities, various research laboratories, animal shipping/staging/support spaces, mechanical yard, and parking .

XOMA THERAPEUTICS Berkeley, CA

Type: GMP & cGMP Fermentation Suite Size: 5,000 SF and 12,000 SF

NEKTAR THERAPEUTICS San Carlos, CA

For the 5,000 SF Fermentation Suite, AlfaTech provided full design and construction management for its GMP new 2,000 liter fermentation suite along with validation support. Design for the 12,000 SF Suite provided a new cGMP fermentation suite consisting of 50 L, 130L, 500L, 2750L, and 12,000L fermenters. These were fully automated with CIP and SIP capability. In addition, a number of media preparation and purification vessels were specified.

BBRAUN* Site Master Planning, Irvine, CA

Type: Laboratory, Office, Manufacturing Size: 4,000 SF

Responsible for the Site Master Planning Options development and the Facility Planning, Evaluation of criteria and constraints, Developing Options for Steering committee selection. Projected $300 million project

AlfaTech provided design services for the consolidation of the central data center, which will occupy approximately 4,000 SF in a currently unoccupied space for Building 3.

* Completed by AlfaTech principal during previous employment

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

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

VIVUS

NOVARTIS (CHIRON)*

JANSSEN PHARMACEUTICALS*

Lakewood, NJ

Vacaville, CA

Vacaville, CA

Type: Laboratory, Manufacturing Size: 80,000 SF

Type : VMF OLWX Project Manufacturing Facility Expansion Size: 17,000 SF, two-story building

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

AlfaTech acted as the owner’s principal engineer for design of a facility that expanded their capacity to formulate and produce a new drug and drug delivery system. The scope of work involved HVAC, process utilities, R.O./D.I. and hot USP water systems, production room layout, and general engineering support. AT also worked closely with the validating agency to provide a complete turnover package.

Full Civil and MEP design services for a 17,000 SF two-story building expansion. The expansion included private offices, open office areas, meeting, conference and storage rooms, corridors, stairs, restrooms, elevator, QA/QC engineering document storage room, QC and raw materials laboratories and process equipment storage, in the following cGMP areas: weigh/dispense room, quarantined and released materials.

BAXTER HEALTHCARE Hayward, CA

NOVARTIS (CHIRON)* San Carlos, CA

Type: cGMP Laboratory

This Hyland Division Laboratory renovation project involved a complete remodel and relocation of the biotechnology process rooms. Construction documents and validation for a cGMP upgrade of the existing facility were also required.

Engineering Design for multiple facility projects including: • Temperature Control for CSD-1 Dryer • Laboratory Humidification System Replacement • Site Energy Manager (Staff Augmentation) • Sitewide Electrical Power Study and Maintenance Plan • Niro-2 Exhaust Modifications (Design/Build Project Delivery)

COLLAGEN AESTHETICS INC. Fremont, CA

• Code Studies • Data Center

NOVARTIS (CHIRON)* Emeryville, CA

Type: Manufacturing Plant Size: 12,000 SF Facilities: • Bulk Processing Area Addition • Office Space Tenant Improvements • Warehouse and Office Space

PAR, FAIRBANK OSD* Facility Master Plan, Irvine, CA

Architecture and Engineering Design for multiple facility projects including: • Site Wide Energy Efficiency Study • Building 4 Lab Tenant Improvements • Robotics Lab Tenant Improvements • Building 4 Executive Conference Center • Building G&T Chilled Water System Upgrades Concept Design

Responsible for Master Planning, Options Development, Programming, and Conceptual Design of the facility. For an existing 90,000 SF OSD Facility that includes manufacturing, QC lab, lab support, warehousing and administrative functions

Collagen Aesthetics Inc. develops, manufactures, and markets on a worldwide basis high quality biocompatible products for the treatment of defective, diseased, traumatized or aging human tissues. This project modified existing Class 100 – 10,000 spaces for laminar flow filling suites for new product manufacturing. The firm maintains Collagen’s library of as-built drawings to support ISO 9001 certification.

* Completed by AlfaTech principal during previous employment

INNOVATIVE IDEAS | INTEGRATED SOLUTIONS | SUSTAINABLE PARTNERS

LOS ANGELES

SAN JOSE

SAN FRANCISCO

510 West 6 th Street, Suite 1105 Los Angeles, CA 90014

One Post Street, Suite 2200 San Francisco, CA 94104

1321 Ridder Park Drive, Suite 50 San Jose, CA 95131

213.212.9860

415.403.3000

408.487.1200