Abstract
Design and assessment activities associated with a biopharmaceutical process are performed at different levels of detail, based on the stage of development that the product is in. Preliminary "back-of-the envelope" assessments are performed early in the development lifecycle, whereas detailed design and evaluation are performed prior to the construction of a new facility. Both the preliminary and detailed design of integrated biopharmaceutical processes can be greatly assisted by the use of process simulators, discrete event simulators or finite capacity scheduling tools. This report describes the use of such tools for bioprocess development, design, and manufacturing. The report is divided into three sections. Section One provides introductory information and explains the purpose of bioprocess simulation. Section Two focuses on the detailed modeling of a single batch bioprocess that represents the manufacturing of a therapeutic monoclonal antibody (MAb). This type of analysis is typically performed by engineers engaged in the development and optimization of such processes. Section Three focuses on production planning and scheduling models for multiproduct plants.
Highlights
Design and assessment activities associated with a biopharmaceutical process are performed at different levels of detail, based on the stage of development that the product is in
Additional goals may include answering some of the following questions: Can the product be manufactured in an existing facility or is a new plant required? What is the total capital investment for a new facility? What is the manufacturing cost? How long does a single batch take? What is the minimum time between consecutive batches? Which process steps or resources are the likely production bottlenecks? What process and equipment changes can increase throughput? What is the environmental impact of the process? Which design is the “best”
The following operating assumptions were made for this step: (1) the resin’s binding capacity is 40 g of product per L of resin; (2) a gradient elution step is used with a sodium chloride concentration ranging from 0.0 to 0.1 M and a volume of 5 column volumes (CVs); (3) the product is recovered in 2 CVs of eluant buffer with a yield on monoclonal antibody (MAb) of 90%; and (4) the total volume of the solutions for column equilibration, wash, regeneration, and rinse is 16 CVs
Summary
One of the central goals of bioprocess design and analysis is to determine what resources are required to produce the desired annual amount of product. Multiproduct plant modeling tools play a very important role in production planning and scheduling They facilitate capacity analysis and long term planning, and enable day-to-day production scheduling by accounting for constraints related to the limited availability of resources such as equipment, labor, utilities, material inventories, etc. The solutions generated by ERP/MRP II tools may not be feasible, especially for complex multiproduct facilities operating at high capacity utilization This often leads to delayed orders, which require expensive expediting and/or necessitate the maintenance of large inventories in order to provide customer responsiveness. Sensitivity analyses are greatly facilitated by process simulation tools as well The objective of these studies is to evaluate the impact of critical processing parameters on key performance indicators (KPIs) such as cycle times, plant throughput, and production cost
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