Dynamic Standard Framework
7.1 Introduction
In this chapter, the potential commercialisation process is presented for the standard framework proposed in this thesis, focusing on its application in the area of biopharmaceutical manufacturing capacity management. Furthermore, it must be noted that while the market for commercialisation is mainly model developers, the end users of the models must also be taken into account when considering its commercialisation.
7.2 Application of the Standard Framework
The framework developed is primarily a methodology aimed to be used by modellers when approaching a modelling problem. The methodology consists of four major phases, Problem Structuring I, Problem Structuring II, Design and Construct, each of which guide the modeller in efficiently mapping the real system onto the chosen modelling platform in such a way as to meet the requirement specifications of a
‘good’ model. The methodology in its very nature is not platform specific and can guide any modelling practice across all industries. Thus the scope for application is vast.
However, the methodology has incorporated into it a set of templates which are designed to help in the construction phase of the modelling process and it is these templates which are platform specific, requiring a certain set of computer system requirements for their application. Figure 7.1 shows the infrastructure of the relationships within the application of the framework. Furthermore, these templates have been designed to be used for a specific scope, which the following section will discuss.
7.2.1 Application Area of Templates
Due to the extensive work carried out in building biotechnology based models, the templates have inevitably been developed for this application area. The parameters captured in the database, the output data generated and the template blocks themselves have been designed to deal with the complexities inherent to biopharmaceutical manufacturing capacity management. For example, production scheduling, single/multi-product procedures, ancillary activities and activities with associated cycle times.
7.2.2 Requirements for Template Application
The work carried out during the course of this research was specific to the Extend modelling environment, chosen due to the modelling preferences of the collaborative company, Eli Lilly and Corporation. The requirements for the use of these templates are as follows:
- The templates were created in Extend Version 7.06 and therefore must be used in version equal to or more recent than this. The lack of backward compatibility with this platform means that while the templates can be used in future versions, they cannot be used in older ones.
- Microsoft Excel must be available in order to use the database template. This input file as well as the output data file have been designed to automatically communicated with the Extend Platform and their presence is integral to the correct running of the model and block templates.
Similarly, if the model and its data capturing components are built in the Extend and Excel platforms, it is necessary for the end user to also hold a license for these platforms, following the specifications given above.
Figure 7.1 Infrastructure of Framework Application
7.3 Project Implementation
An example is given of an implementation scenario which involves a modeller (e.g.
within a large-scale biopharmaceutical manufacturing company) being approached by the client (e.g. team running a new in house facility for the production of a biosynthetic therapeutic).
A chronological implementation plan is presented here of the key project phases as outlined in the proposed methodology.
7.3.1 Problem Structuring Phase I
- Client approaches modeller with capacity management issue
- Modeller establishes the scope of the problem, gaining an understanding of the desired inputs and outputs, the data available and the desired metrics to measure against i.e. what is the client aiming to measure process performance against.
The list given in Table 3.4 (in Chapter 3) can be used to aid this.
- The model is then characterised based on the established requirements. For example, whether single or multiple activities, dynamic or static, metric etc. In this case, since the problem is associated with biopharmaceutical manufacturing
capacity management, it is assumed that the model can be classified as ‘Extend Manufacture’.
7.3.2 Problem Structuring Phase II
- Modeller builds a non-coded description of the system using process terminology
- The system description is validated with client to ensure fully captured elements - Description is tweaked and revalidated if necessary
7.3.3 Design
- Modeller creates a process specific description of the system, using model terminology. For example, tasks become sub-activities.
- Gaps highlighted here can be filled by returning to client. For example, constraints or cycle times which have not been captured.
7.3.4 Construct
- Modeller creates a coded description of the system, using the templates to map the system elements onto the modelling platform based on the model design.
- Debugging follows first phase of construct completion
- Using initial model outputs, validation can take place, comparing outputs with expected results from client
7.3.5 Project Handover
- Model is presented to client followed by training on how to use the model - Project is handed over to client along with documentation
7.4 Project Costing
The resource requirements and costs have been estimated based on a typical industrial project. The assumptions made are as follows:
- Although both modeller and client are in-house, the modeller is assumed to be working on the project as a consultant, using an opportunity cost basis for determining costs associated with time spent on this project. The costs for the modeller have been assumed to be £20 per hour (lower than general consultancy rates due to in-house employment status), working a 40 hour week.
- It is assumed that the modeller holds a license for the required modelling platforms. Therefore the client will incur the cost of a run-time license fee, which will not include maintenance or support fees.
- Both the modeller and client own licenses for Microsoft Excel and therefore no costs are incurred
- Table 7.1 shows the estimated project cost to total £8,080 with the project duration being approximately 50 days.
Table 7.1 Project costing and task durations
Task Duration Resource Cost (£GBP)
Problem Structuring Phase I
2 days Modeller 320
Problem Structuring Phase II 10 days Modeller 1,600
Design 5 days Modeller
Microsoft Excel
800 - Construct inc debug 30 days Modeller
Extend
Microsoft Excel
4,800 - - Project Handover 3 days Modeller
Extend