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Designing a robust and cost-efficient monoclonal antibodies (mAbs) manufacturing facility is a significant challenge in the life sciences industry due to the difficulty of forecasting product demand and production. By integrating process simulation, coupled with capital and operating cost estimation, one can benefit from an efficient method of evaluating alternatives to find an optimized design.
The common design alternatives listed below provide a sense of the scope of the optimization:
- Throughput, usually defined as the number and size of the production bioreactors, is a key variable. Batch timing and cadence also contribute to throughput modelling. Consideration must also be given for making disparate products concurrently in the same facility.
- Some cell culture processes are strictly batch, while others are semi-batch or perfusion. This will influence the size of the equipment and the media delivery strategy.
- Chromatography and ultrafiltration/diafiltration operations require multiple buffers. These may be produced and delivered for each main product batch entailing many small volume preparations with little buffer storage but may be labour intensive. Alternatively, buffers may be multi-batched (where one buffer batch provides for multiple product batches), or buffer concentrates may be used, which will reduce preparation batches, saving labour. Additionally, central storage and distribution systems for standard buffers, such as various caustic concentrations, are often utilized.
- Buffer storage will be a function of multi-batching and use of concentrates also. This decision will impact the WFI use profile and the design of the utility supply system.
- The location of equipment within separate suites or ballrooms impacts the facility’s cost, affects campaign changeover and hence throughput. Typically, one batch or product is allowed in a suite at one time. The equipment and suite may require more intense cleaning between campaigns which is unproductive time for the facility.
- Stainless steel equipment vs. single-use systems is a critical decision that will impact equipment cost, CIP, and water system design. Disposables will save on several costly elements of the facility but will entail purchasing expensive, single-use consumables, increased labour, increased solid waste, and will require additional staging space. This is evaluated as a transfer of capital cost to operating costs.
- Future needs such as increased titers, additional products, or throughput expansions impose design constraints or demands on the facility.