<p>Developments in the technology are followed by
the methods and frameworks in industry to intensify the production of
information, tools, goods, and services. This trend has been followed by the
pharmaceutical industry which is highly regulated by administrations to meet
the quality requirements of the drugs and produce more for cheaper in a shorter
time. As the knowledge and understanding of crystallization systems have been
increasing with the development of process analytical technology (PAT) tools,
it is inevitable to use the experience and data coming with it to develop
data-driven, better processes. In the light of these developments, Industry 4.0
has started becoming the new paradigm in pharmaceutical industry pushing the
data-driven design of pharmaceutical processes. This thesis demonstrates the
development and usage of a framework for data-driven, model-based design of
pharmaceutical processes that fall in line with this latest paradigm shift. The
proposed framework can be summarized in four levels showing the benefits of the
collected data and model development. These levels are data collection from
specially designed experiments, model writing, using the data collected from
the first step to train the model, validation of the model to call it ‘Digital
Twin’ of the process, using the digital twin for process design via in-silico
design of experiments (DoE) or process optimization. The chapters in this
thesis are different case studies that follow these steps for model-based
process design. The systems studied are batch cooling crystallization with
temperature cycling to produce a drug compound, batch cooling crystallization
with integrated milling and temperature cycling for the shape optimization of
the same drug compound from previous step, and hot melt extrusion for
amorphization of another drug compound. In addition to demonstrating the
development of the whole framework and its possible benefits in each chapter,
Chapter 4 is the solely experimental proof of concept of a previous, more
general model-based design of a mill integrated crystallization work.</p>
| Identifer | oai:union.ndltd.org:purdue.edu/oai:figshare.com:article/17161484 |
| Date | 18 December 2021 |
| Creators | Ayse Eren (11818946) |
| Source Sets | Purdue University |
| Detected Language | English |
| Type | Text, Thesis |
| Rights | CC BY 4.0 |
| Relation | https://figshare.com/articles/thesis/Model-Based_Design_of_Pharmaceutical_Crystallization_Processes/17161484 |
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