Building 100E - Lonza Bioscience

Walkersville, MD

Encon provided project management, detailed design and preconstruction services for a 35,000-square-foot Greenfield building. The design incorporated cGMP manufacturing and support areas for cell culture and down-stream manufacturing activities and was designed to meet FDA regulatory requirements. Process equipment and utility design included water pretreatment and USP purified water generation and distribution, a continuous heat in-activation biowaste kill system, biohazard decontamination steam autoclaves, vaporous hydrogen peroxide decon-tamination systems, and cell culture media waste removal equipment.

Included in the project’s design is a 6 megawatt backup generator facility consisting of four diesel fired generator sets, 10,000 amp paralleling gear, main power distribution gear, and multiple automatic transfer switches located throughout the campus.

Soliris Manufacturing Facility for Alexion Pharmaceuticals, Inc.

Smithfield, RI

Encon provided Alexion Pharmaceuticals with a full range of engineering services in their search for and renova-tion of an appropriate building for their large-scale biotechnology manufacturing processes. Services provided included site selection, process development, test-fit, conceptual development, engineering design, procure-ment, and construction management.

The facility was designed to FDA and EU regulatory requirements. The design included a cGMP mammalian cell culture production train with two 10,000L bioreactors and harvest tank. Support functions included media prep, buffer prep, and buffer hold. Downstream processing functions--pre- and post-viral purification suites and bulk filling--were also provided. A pilot plant for development of biotechnology products that was integral to the main manufacturing area was also included in the project.

All process and building utilities were upgraded. New water pretreatment, WFI production, and distribution sys-tems were installed, including a 9,000 lph vapor compression still, hot and ambient WFI distributions loops, and a pilot plant WFI system that was isolated from the production WFI system. A new clean steam generation and distribution system was also provided.

Process piping systems, providing the automated operation of five CIP systems and multiple product (media, buffer, and cell culture) transfer systems, were also included in the design. All production area HVAC systems were redesigned to be compliant with current FDA and EU requirements. New air han-dling units and ductwork systems were installed. The central plant chilled and condenser water systems were redesigned.

Facility Planning and Parenteral Manufacturing Suites - Chesapeake Biological Laboratories, Inc.

Baltimore, MD

Encon has provided multiple facility and process upgrades for Chesapeake’s Baltimore facility including:

Conceptual planning and design for the retrofit of an existing vaccine facility to accommodate BL-2LS manufac-turing of multiple parenteral products. The design was intended for FDA cGMP and EU regulatory compliance. New high purity and plant utilities were provided and included USP water pretreatment, water for injection gen-eration and distribution, bio-kill, and clean steam systems. Upgrade and replacement of autoclaves, depyrogena-tion ovens, and production lyophilzers were included.

Quality control and microbiology clean rooms designed to support quality testing and facility monitoring for par-enteral drug manufacturing. Design solutions included FDA high purity utility systems, expanded facility chilled water system, compressed gas and vacuum utility systems, bio-safety cabinets, and a high pressure steam sys-tem expansion for the existing plant.

Expansion of existing aseptic manufacturing for accommodation of increased lyophilization capacity with room pressurization modifications and phased construction requirements

North American R&D and Manufacturing Facility - QIAGEN Sciences, Inc.

Germantown, MD

Encon provided QIAGEN Sciences with engineering services in their design and construction of a 220,000 square-foot facility consisting of laboratories, manufacturing, warehouse and distribution areas.

Services included infrastructure design and review of design documents for all utlity systems, piping design meth-odology, equipment sizing and selection, and construction methods and materials.

Other subsequent projects have included:

• Site and facility master planning for up to 500,000 square-feet and 600 personnel.
• Manufacturing and laboratory expansion for DNA and siRNA oligoneucleotide synthesis featuring large scale haz-ardous material delivery and waste collection systems.
• An build-out of 30,000 square-feet of office, laboratory and laboratory support spaces.
• Medical device assembly.and packaging expansion, featuring a dedicated HVAC system for Class 100,000 clean manufacturing area designed to cGMP standards.
• Pilot Plant expansion of manufacturing space for development of cGMP medical devices

Huntsville Biotechnology Institute

Huntsville, AL

Encon provided conceptual development and programming for Operon’s planned DNA and siRNA oligoneucleotide manufacturing facility. The design included DNA and siRNA synthesis suites, QC testing laboratories, warehouse and distribution areas, and chemical storage facilities conforming to cGMP and EU regulatory reuirements.

Programming and space planning was performed to enable utilization of lean manufacturing principles for minimiz-ing personnel movement while maximizing performance efficiency.

HVAC systems were planned for maintaining tight control of environmental conditions within the manufacturing suites to protect the integrity of highly sensitive DNA and siRNA products. Specialty systems for the storage and automated distribution of high hazard liquids utilized in the synthesis suites were designed.

Osiris Tissue Proccessing Suites

Baltimore, MD

Encon provided conceptual development and detailed design services for Osiris’ new multi-product tissue proc-essing and packaging suites within their existing operational facility. The design provided segregation for concur-rent processing and packaging of multiple products and conformed with FDA cGMP and EU regulatory require-ments.

Preconstruction and procurement services were also provided. Encon developed bid packages, administered the competitive bidding process, evaluated and recommended award of the general construction package. Technical specifications and bid packages were also developed for manufacturing process equipment that was to be pre-purchased.

Lonza Bioscience Site Master Planning

Walkersville, MD

Encon has performed planning and feasibility analysis for development of the 166 acre Lonza site located in Walkersville, Maryland. Detailed aerial and boundary mapping was completed to create an up to date topographic and landmark property survey.

The feasibility analysis included investigation of site’s sanitary sewer, potable and storm water management is-sues, town zoning and wellhead protection regulations, site access and traffic management considerations, the site’s physical characteristics including slopes, floodplain, presence of wetland’s, forest conservation require-ments, and preliminary infrastructure engineering issues.

The site’s constraints and opportunities were assessed and evaluated for development potential and recommen-dations for placement of future site development were outlined.

Existing capacities of and feasibility of future expansion capacity for the site’s gas and electric power utilities were investigated.