More Capacity Doesn’t Always Require More Equipment.

How process concept design supported by simulation helped optimize a large-scale mAb manufacturing facility, identifying opportunities to eliminate more than 40 major equipment items while maintaining planned production capacity.

Increasing biopharmaceutical manufacturing capacity often raises an obvious question: What additional equipment will be required?

But that may not be the right place to start.

Equipment requirements should be determined by the performance of the entire process, not simply by replicating existing production lines.

In a monoclonal antibody facility expansion project, ZETA developed the process concept and used simulation to challenge initial equipment assumptions, identify underutilized capacity and optimize the facility design.

A biopharmaceutical manufacturer planned to substantially increase monoclonal antibody production capacity through three new production lines.

Replicating upstream, downstream and supporting equipment across all three lines was one possible approach. But would that configuration deliver the most efficient use of equipment, capital and operational resources?

The challenge was not simply to achieve the required production capacity. It was to determine where capacity was actually needed, where equipment could be shared and how different process technologies would affect capital investment and long-term operating costs.

The decisions that shape manufacturing economics begin well before equipment is purchased. The customer needed a concept design grounded in process performance, not equipment assumptions.

ZETA began with the process engineering required to define the facility concept across upstream, downstream, media and buffer preparation. INOSIM process simulation was then used to test how those operations would perform together as an integrated system.

The simulation assessed production capacity, equipment utilization, utility requirements and operator demand to identify opportunities for optimization.

Rather than assuming each production line required a complete set of dedicated equipment, ZETA evaluated where equipment could be consolidated while maintaining the required production capacity.

The study also compared single-use, stainless steel and hybrid technology configurations, supported by cost-of-goods analysis. Capital and long-term operating costs were evaluated together so that operating economics could inform the engineering decisions, not simply be calculated after the design was established.

The objective wasn’t simply to validate a proposed equipment configuration. It was to determine which configuration best supported the manufacturing requirements and economic objectives.

The simulation revealed a 46-percentage-point difference in equipment utilization. Main bioreactors reached 91% utilization, while downstream equipment utilization was only 45%.

That difference challenged the assumption that increasing upstream production capacity required a proportional increase in downstream equipment.

By evaluating the integrated production process, ZETA identified opportunities to consolidate seed train, harvest and downstream operations across the three production lines.

In an optimized example configuration, the required modeled capacity could be maintained with substantially fewer equipment items.

Buffer preparation presented another opportunity. Instead of replicating conventional buffer preparation and hold systems, the team evaluated inline dilution to reduce preparation requirements, storage volumes and facility footprint.

Technology selection was also evaluated at the process-area level. Single-use, stainless steel and hybrid configurations were compared against operational requirements, utility consumption and cost-of-goods implications.

The resulting concept reflected the needs of the overall manufacturing process rather than a blanket preference for any single technology.

More than 40 major equipment items were eliminated from the optimized example process configuration while maintaining the required modeled production capacity.

The equipment reductions resulted from consolidating operations and improving how equipment was utilized across the three production lines, rather than compromising production requirements.

The final concept incorporated single-use bioreactors, stainless steel harvest equipment, hybrid downstream processing and inline buffer dilution.

Beyond equipment consolidation, the study provided a structured basis for evaluating capital and operating costs, utility requirements and technology alternatives.

The broader lesson is clear: Increasing manufacturing capacity shouldn’t automatically mean increasing equipment capacity proportionally.

By simulating the integrated process during concept design, engineering teams can evaluate equipment requirements, identify underutilized capacity and make more informed investment decisions before equipment configurations are finalized.

Optimizing large-scale bioprocessing facilities requires understanding how individual process operations interact, identifying system-level constraints and addressing them early in facility design.