New Research Lab Facility

Discovery Life Sciences (DLS) hired SSOE for the laboratory programming and planning for a new building to be located at their Huntsville, Alabama discovery center. DLS was looking to consolidate multiple laboratories under one roof to increase efficiency and modernize their laboratory spaces.

SSOE’s planning expert collaborated with the client user groups to create a program and optimized program customized to fit their unique needs. Working alongside the eight different laboratory user groups, the SSOE team generated a program that included space for a planned 25 percent growth across each of DLS’s business units.

After right-sizing DLS’s program, SSOE’s planning team created adjacency diagrams and blocking diagrams to plan out where different business units needed to be located within the building. One area that necessitated special consideration was the bio-repository, which needed to be centrally located within the building due to the potential risk of damage from natural disasters.

SSOE generated a program that consisted of just over 90,000 SF, utilizing a modular planning concept to allow future flexibility and adaptability. Laboratory spaces include wet research labs, a cleanroom, a BSL-3 laboratory, and genomics spaces.

The project’s flexibility and adaptability were tested when the genomics program director changed just as our team was finalizing construction documents. We swiftly pivoted, transforming the genomics space from an open lab into three separate labs, complete with anterooms and pass-throughs to accommodate the product

The genomics sequencing rooms house 30 sequencers, each of which emits a significant amount of heat. To address this, our team meticulously planned the space, incorporating specialized cooling and exhaust systems. These systems are connected to emergency power, ensuring that there will be no interruption to services in the event of a power outage.

Additional spaces include a cell services and processing lab, infectious disease, proteomics lab, donor center, immunohistochemistry services lab, histology, pathology lab, specialized biorepository for tissue samples in freezers, paraffin and slide-based samples, and shipping and receiving logistics room.

SSOE worked with the DLS to select the laboratory equipment and coordinated with equipment suppliers to ensure the required infrastructure was integrated to support the selected equipment. This project led to subsequent initiatives with DLS that persist to this day.

Laboratory Planning and Design

HCW Biologics needed to grow its operation and turned to SSOE to scale up. The client is transitioning from research and development to clinical trials for oncological and age-related medicine. With our Design-Build partner BE&K, SSOE provided full-service programming and planning, architecture, and engineering for the renovation of a 40,000 SF existing office, and warehouse space to be repurposed as laboratories, cGMP production spaces, warehouse, and support spaces.

Through workshops and collaboration with the scientific staff, our team generated a flexible and adaptable research laboratory. We worked with the client to develop their new production facility and guided the client through the development of their manufacturing procedures and established a Quality Assurance / Quality Control process.

Because the pharmaceutical industry is repatriating the drug manufacturing process, SSOE understood the client’s need to fast-track this project. Our national lab planner worked with HCW Biologics to ensure we were not repeating their smaller-scale configuration. Instead, we listened to the client to know what did and did not work in their limited operation to provide a more successful spatial arrangement in the designs for the larger operation.

SSOE designed spaces for specialty research labs including bioreactor, process, and microbiology, in addition to tissue culture and research laboratories. The new 5,000 SF cGMP cleanroom environment includes ISO 7 production labs and an ISO 6 sterile filling suite.

Finally, the project also included the addition of a new 1,000 SF vivarium space that is supplemental to animal holding including procedure rooms, isolation, and support spaces to facilitate vivarium operations. SSOE provided programming, planning, architecture, interior design, fire alarm, fire protection, technology, and structural, mechanical, electrical, plumbing, and process engineering for the project. Construction will be completed in March 2024.

New API Manufacturing Building

SSOE assisted a leading global life sciences manufacturer with developing Conceptual Design (FEL I), engineering estimates, and a program schedule for a new Active Pharmaceutical Ingredients (API) facility located in the Midwest. Forecasted demand for existing products cannot be accommodated within the owner’s existing facilities. As a result, SSOE developed a building concept to accommodate the increased manufacturing space, increased QA/QC and Micro Lab space, Stability Chambers, Product Development spaces, and general meeting and assembly spaces. The study also included investigating possible placement of the new building on the existing campus or locating it on one of two neighboring properties.

SSOE’s pharmaceutical design team collaborated closely with the client to create building conceptual design and site layout options, budgets, and an overall project schedule. SSOE fully integrated its Construction Management team into the project from Day 1 to provide a high level of estimate and schedule accuracy.

Building Highlights

  • The building network, instrumentation, and process equipment are being designed to allow full digitization of the manufacturing process.
  • The building will be comprised of ISO 7 (Micro Lab), ISO 8, ISO 9, CNC, and mechanical spaces.
  • Purified water (PW) and deinonized water (DI) generation systems will support manufacturing and laboratory spaces respectively.
  • Compressed gasses will be centrally located, and fully piped and instrumented delivery systems will serve both the production and lab spaces to completely eliminate the need for gas cylinders to be moved around inside the building.
  • Currently in Capex Funding Phase, detailed design is scheduled to begin in fall of 2021.
  • The estimated production start date is the 4th quarter of 2023.

Using IPD to Help Our U.S. Client Expand into Mexico’s Consumer Health Market

One of our long-standing consumer products clients recently acquired several product lines from a global healthcare company’s consumer health division. To expand further in the Latin American markets, they wanted to create a production facility in Mexico. After a recommendation from a general contracting partner in Mexico, they short-listed our team to provide design engineering services and ultimately hired us based on our knowledge of Lean tools and delivery methods, our relationship with the client’s U.S. counterparts, and our ability to work locally.

Still underway, the new three-story, 50,000 SF freestanding facility is being built in a fully Integrated Project Delivery (IPD) environment. Although we’ve completed projects at varying degrees of Lean intensity, this is SSOE’s first Integrated Form of Agreement (IFOA)—a contract that incorporates Lean practices and establishes shared risk and reward with our client and three trade partners to tie team success to project success.

The SSOE-designed facility will produce solid oral dose tablets for over-the-counter distribution in a growing market on our client’s existing campus. Our team is also providing process design, validation, and start-up services, bringing in a resource in product development to assist with formulation transfers and technology selections. By having project activities occur concurrently, it is allowing and engaging early contribution of knowledge and expertise of contractors in key trades.

The design phase is complete and construction is underway. SSOE has a full-time engineering resource on-site as a single point of contact for the trade partners and client. This full-time presence is a significant investment, but we believe the time savings associated with rapid information flow and increased quality control makes this a cost and time savings approach.

Coated Vitamin Tablet Production Increase

In an effort to double its current coated tablet production capacity, a leading nutraceutical manufacturer requested SSOE provide architectural, engineering, and construction management services to increase its production area by approximately 3,500 SF. SSOE led the design for simultaneous operation of two separate tablet coating processes, which included the installation of tablet coating equipment and utilities, an air handling unit with dust collector and blower, conveyor systems, a bulk unloading system, and relocation of the deionized water system. To allow for the capacity increase, SSOE designed expansions to the manufacturing area by utilizing available floor space for a new tablet coating room with auxiliary rooms for cleaning. Our structural team calculated and designed requirements to maintain structural integrity to support the new equipment.

SSOE’s structural, process / utilities, mechanical, and electrical disciplines provided a wide range of engineering services for process design and equipment layout. Our project management team developed the project budget and installation schedule, and oversaw contractor bid reviews and vendor drawing reviews. We also provided construction management services to reduce the cost of hiring a general contractor and matched hours to the project schedule requirements.

Our project team came through in the clutch by quickly adjusting to a “crash schedule” due to delayed project approval, and completed all installations by the established project completion date. In an effort to remain on schedule throughout the project duration, SSOE’s on-site construction management personnel worked weekends, holidays, and extended work week hours to make this project a success.

Gummy Vitamin Line Production Increase

SSOE has documented nearly $2 million in savings, including $1.6 million for the AMS upgrade project, $153,000 for the tray washer project, and $101,000 for the first set of conditioning rooms, corn syrup tanks, and kitchen platforms.

To keep up with consumer demand, a leading nutraceutical manufacturer needed to double its current gummy vitamin production capacity—increasing the current production area by approximately 8,200 SF. SSOE led the design for simultaneous production of multiple colors and flavors, which required modifications to the up front unit operations and an upgrade to the existing Additive Mixing System (AMS). Installation of bulk truck unloading transfer piping with heat tracing and two new 5,000 gallon corn syrup tanks was also included in the project scope. To allow for the capacity increase, SSOE designed expansions to the manufacturing area, seven new conditioning rooms, and a mezzanine to support a new heat exchanger without taking up valuable floor space. Our structural team designed safety enhancements in the kitchen areas by designing new access platforms. Additionally, SSOE designed a new COP room to accommodate new tray washing equipment to satisfy the flow of operations.

SSOE’s structural, process / utilities, mechanical, and electrical disciplines provided a wide range of engineering services for process design and equipment layout. Our project management team provided the project budget development and installation schedule, and oversaw contractor bid reviews and vendor drawing reviews. We also provided construction management services to reduce the cost of hiring general contractors and matched hours to suit the project schedule needs.

Due to delayed equipment arrival, the SSOE project team needed to quickly adjust to a “crash schedule” as the project moved toward completion. Understanding the urgency for speed to market, SSOE’s on-site construction management personnel worked weekends, holidays, and extended work week hours to meet the client’s desired completion date.

SSOE has since provided ongoing design and engineering services for this client, supporting the manufacturing of a variety of gummies including prenatal and food-based vitamins as well as fiber supplements.