This activity is only really valuable if the model developer truly understands the process and can rely on other in-house expertise and be able to ask the right questions when setting up the model with the client. The model can be as simple as a single spreadsheet for a single CIP skid loading or full train integrating various manufacturing areas (e.g. utilities, media/buffer prep, fermentation and recovery/purification). For the majority of applications we use Designer Pro backed up by EXCEL and Visual Basic as necessary.
The outputs from the models allows us to perform a quick modeling effort based on production capacity parameters to generate timelines (Gantt charts) and resource histograms, identify bottlenecks within process or support systems, and determine the impact of debottlenecking solutions. We can also perform an economic analysis of manufacturing operations and facility designs, including payback and cash flow analyses and report generation.
We use a desired production capacity to model the process and optimize the usage of equipment and support systems. "What if" scenarios are developed to determine potential bottlenecks (e.g., capacity increase, batch size, multiproduct capability, process variations). Proposals of optimized debottlenecking solutions for prioritized future plant requirements can be incorporated into the initial design to achieve process flexibility and minimize overall capital cost.
Katalyst Bio Engineering provides Bioprocess engineering consultancy services to the Biopharmaceutical and Biologics industry. Our consulting philosophy is to integrate process, engineering, automation and compliance expertise to support each phase of the project lifecycle. The consultancy services start from conceptualization to commissioning through validation of the facility.