Project Brief

KeRi provided Mechanical, Electrical, Plumbing, and Fire Protection (MEP/FP) design for a 25,185 SF biosimilar facility built to FDA and ISO guidelines, combining R&D laboratories with Class II Type A2 and Type A1 biosafety cabinets, cleanrooms for upstream and downstream processing, and their associated support spaces. Rather than build the cleanroom envelope from scratch, the project converted existing cleanrooms to serve the upstream and downstream process trains.

The converted space carries the process through buffer preparation, purification, and filling. Buffer prep and the process trains run on skids ranging from 50 litres to 500 litres, and the purification room houses an AKTA chromatography system. New refrigerators and freezers were added for cold storage of in-process material and final product, so each room had to be served with the utilities, power, and classified conditions its equipment and its step in the process demand.

The existing HVAC systems were reused wherever they could still hold the required classified conditions, which took a significant share of new equipment out of the budget. Where new capacity was needed the design provided a 350-ton cooling system and a 6 million BTU heating system on condensing boilers, together with the process utilities, electrical distribution, and cleanroom lighting a working biologics facility depends on.

Adello Biologics, the biosimilars developer formerly known as Therapeutic Proteins International, ran its research and development operations from this Piscataway campus, advancing biosimilar candidates in oncology and immunology.

MEP Engineering Scope

What We Engineered

Fully coordinated MEP/FP, process-utility, power, and lighting systems for the biosimilar facility:

• Conversion of existing cleanrooms to upstream and downstream processing suites
• Buffer preparation, purification, and filling rooms served as classified space
• Support for 50 to 500 litre process skids and an AKTA chromatography system in purification
• Power and cooling for new refrigerators and freezers holding in-process material and final product
• Reuse of existing HVAC systems where they could hold the required conditions, reducing overall project cost
• HVAC with a 350-ton cooling system and a 6 million BTU heating system on condensing boilers
• Class II Type A2 and Type A1 biosafety cabinet support
• Electrical distribution with UPS power
• New cleanroom lighting designed to IESNA illuminance guidelines for cleanrooms
• Specialty plumbing: compressed air, vacuum, helium, nitrogen, and natural gas
• RO/DI and high-purity water systems
• Design of hazardous (classified) spaces
• Fire protection throughout

The Challenge

Buffer preparation, purification, and filling all had to be accommodated inside cleanrooms that already existed, each room holding FDA and ISO conditions around skids from 50 to 500 litres, an AKTA chromatography system, and new cold storage, without the cost and schedule of an all-new cleanroom envelope and central plant.

Our Solution

KeRi converted the existing cleanrooms into buffer preparation, purification, and filling suites for the upstream and downstream trains, and reused the existing HVAC systems where they could still hold the required classified conditions, which reduced the overall project cost. The design added 350 tons of cooling and 6 MMBTU of condensing-boiler heating, biosafety cabinet support, specialty plumbing (compressed air, vacuum, helium, nitrogen, gas), RO/DI and high-purity water, electrical distribution with UPS power, and new cleanroom lighting to IESNA levels.