- #PLANT SIMULATION SOFTWARE BIOLOGY SOFTWARE#
- #PLANT SIMULATION SOFTWARE BIOLOGY PLUS#
- #PLANT SIMULATION SOFTWARE BIOLOGY SERIES#
Serotype D was used to determine the particle density for all serotypes and is marked with an asterisk. The seven different serotypes represented on the x-axis differ in their particle size, stream viscosity and centrifuge residence time and therefore test the ISP model over a range of variables. The pellet weight predicted by ISP is compared to actual process data in Figure 1. This model is based on the Stokes settling model which accounts for the following parameters: particle size, feed stream viscosity, centrifuge residence time, centrifuge sigma factor and particle density. One of the more robust ISP unit operation models is the centrifugation model.
#PLANT SIMULATION SOFTWARE BIOLOGY SOFTWARE#
Two examples of how the software was used to predict unit operation outputs are provided below. ABP is also able to track CIP and SIP operations better than ISP, although there is room for improvement with both packages.Īpplication of Software in a Polysaccharide Antigen Process:ĪBP and ISP were both used to simulate a biotechnology process, specifically the production of a polysaccharide antigen.
Additionally, ABP has extensive heat transfer models and exportable equipment databases. When changes are made to the recipe these changes are automatically reflected in material balances, energy balances, process diagrams and economic evaluations. This recipe format can be exported and used to generate batch records. In ABP the main user interface is a recipe format through which the user enters a detailed processing procedure. ISP allows for reaction kinetics as well as growth curves to be simulated. ISP also contains more complex reaction models than ABP. These PFDs provide an excellent overview of the entire process and allow the user to point and click anywhere in the PFD to gain more information about that step. ISP is very useful for quickly setting-up interactive process flow diagrams (PFDs). In some cases more complex models exist and applications of these models are provided below. Therefore, reaction yields and separation rates are rarely a function of process stream properties or operating conditions. The majority of unit operation models use a constant linear multiplier to convert a component inlet-stream composition to the outlet stream composition. In performing this evaluation it became apparent that most unit operation models in ABP and ISP are very simplistic. Simulation software must take into account the materials, equipment and scheduling required for clean-in-place (CIP) and steam-in-place (SIP) operations. Finally, cleaning and sterilization of equipment and the sterilization of final product are necessary for the production of FDA compliant pharmaceuticals. This overlap between batch and semi-continuous steps can prove difficult to accurately simulate. Third, the pharmaceutical industry often utilizes integration of batch and semi-continuous operations. Second, bioprocesses involve underdefined raw material and products such as cells and proteins for which physical properties or even structures may not be known. These unit operations are not always well characterized and work more on physical and biological phenomena then on the principles of phase equilibrium.
First, unique unit operations such as fermentors, homogenizers, centrifuges, filters and chromatography columns are used. There are several challenges in the application of process simulation software to biotechnology processes. Traditionally, process simulation has been used to model chemical synthesis, particularly the production of petrochemicals.
In ABP and ISP the majority of the unit operation models are steady-state. These models predict outlet stream properties according to the unit operation algorithms, and by drawing additional information from material and equipment databases.
#PLANT SIMULATION SOFTWARE BIOLOGY SERIES#
Process simulation software is a series of computer algorithms modeling the performance of individual unit operations. To aid in evaluation, software was applied to a model vaccine manufacturing process for the production of a polysaccharide antigen and results are discussed below.
Both packages are designed specifically for the biotech/pharmaceutical industry and model batch processing.
#PLANT SIMULATION SOFTWARE BIOLOGY PLUS#
Two software packages have been evaluated to date: Aspen Batch Plus v1.2 (ABP) and Intelligen SuperPro v3.0 (ISP). In particular, we were interested in using this software to aid in technology transfer between research and manufacturing divisions at Merck & Co. The goal of our study was to evaluate commercially available process simulation software on its ability to model biotechnology processes. Marten, University of Maryland Baltimore County
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