Cost-modelling tools facilitate an understanding of bioprocess economics
Sartorius experts use process and cost of goods (COGS) modelling tools to support clients during their early stage process development activities
The ability of biopharmaceutical companies to develop manufacturing processes that deliver low costs of goods (COGS) is becoming more important as the market becomes increasingly competitive. Sartorius uses process cost-modelling tools to understand better the impact of process design and technology choices on overall process throughput and COGS. We can use these tools to determine whether you have a commercially viable process or predict the impact of switching to alternative process configurations.
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Our Integrated Solutions Team develops and implements rapid and cost-effective biomanufacturing solutions from early phase development through scale-up to commercial manufacturing.
Process-modelling expertise at Sartorius
Helping customers identify the most optimized process flows and deliver lowest costs
Our process-modelling experts have received the highest levels of training and have gained significant experience through successfully delivering many diverse projects all over the world. Sartorius experts use process and COGS modelling tools to support clients during their early stage process development activities. The Process Development team use these tools to help our customers identify the most optimized process flows delivering the lowest costs. The analysis software helps to identify specific process scenarios with the potential of having the greatest impact on overall process economics. The information can be used to guide the process scientists and engineers to invest their time and effort into optimizing the steps that deliver the best overall outcome. The analysis can be applied to various technology options to better understand the impact of process design and technology choices on overall process throughput and cost of goods as shown in the graphs below.
Choose the most cost-efficient biomanufacturing approach
Understand manufacturing costs early on in development
Companies can gain valuable insights from process and cost modelling software when considering the design of new biomanufacturing facilities. Increasingly firms have to decide whether to implement stainless steel equipment, single-use technologies or a combination of the two using a hybrid approach. The graph shows a comparison of the costs associated with a stainless steel facility, hybrid facility and a single-use facility.
Use Case 1: Cost breakdown per unit operation
The charts show an example of a typical modelling output for a single-use monoclonal antibody production facility in which 2000 L production bioreactors are being used and the cell line is expressing antibody to a titer of 3 g/L.
The model allocates process costs to the following categories,
- Capital costs,
- Operating costs,
- Consumable costs,
- Materials costs like buffers and media,
- Utilities costs
- Quality costs,
- Other costs such as insurance, waste management.
The outputs of the model include,
- Process flow chart/overview
- Mass balances
- Water utilization
- Process timings – thus giving the total number of batches possible
- Vessel and Bag usage
- Equipment list
- Consumable list
Use Case 2: Batch vs Continuous USP and DSP cost distribution
Once our modelling experts have performed a basic analysis it is possible to compare the cost per batch/year/dose or cost per gram of various different scenarios and for companies to start asking themselves “what if?” questions.
The chart shows cost modelling data, based on a specific set of assumptions, that allows biomanufacturers to assess which combination of continuous or batch upstream and downstream processing will give the lowest costs. The results show that the lowest cost option is likely to be batch upstream processing with continuous downstream processing except at facility throughputs of 10 - 100 Kg/year. In this case, concentrated fed-batch with a continuous downstream is also a viable alternative.
The analysis that is possible with cost modelling tools can also answer more subtle questions around the likely benefits of implementing new technologies that are nonetheless important. Cost modelling requires tools, expertise, and experience but is becoming ever more important in the early and late stage development of biopharmaceuticals so that firms can optimize their processes and maintain their advantage in an ever more competitive environment.