Manufacturing automation within the supply chain to ensure patient safety

The cell therapy industry is offering huge opportunities to transform the way healthcare is delivered. However, the current
amount of manufactured goods is limited and the manufacturing processes require drastic transformation to be able to
respond to the potential demand. This proposal will aim to create a demonstrator that allows flexible manufacturing by
automating the storage and retrieval of sample vials from multiple large capacity Cryogenic storage devices. Adopting this
technology / solution requires the cell therapy sector to develop an integrated supply chain to enhance the number of
manufactured goods. The current project will first stabilise and subsequently grow robust pharmaceutical supply chains.
In order to achieve this, the project will develop and implement novel rapid prototyping and manufacturing capability at
Fisher Bioservices. This design-led approach will reduce risk in the early stages of the development process, thereby
dramatically improving attrition rates and return on investment. The company will be recognised as leading the
transformation of developing cell therapy goods. The benefits are not limited to the company, its clients and supply chain
partners but will be realised across the whole value chain, including patients and wider society.
Cranfield's main role focuses on investigate the improvement options to address the bottlenecks identified. This will look
into developing tools and processes improving the manufacturing and supply chain. In line with the main aim of this WP,
the following objectives are defined:
1. Review suitable simulation approaches (Linear Optimisation, Discrete Event, Agent Based, and System Dynamics). This
will incorporate recent research in Gene Therapy, Aerospace and Defence
Manufacturing (which are relatively low-volume, highly advanced technological manufacturing)
2. Design and develop computerised simulation models to optimise the manufacturing (and supply chain) workflows. This
will involve using commercial off the shelf software packages and bespoke
tools developed for improving decisions in automation.
3. Develop an innovation roadmap to embed the findings from the simulation models which will feed into WP3
(DEVELOPMENT OF A MODULAR INTEGRATED AUTOMATED CRYOGENIC STORAGE
ARCHITECTURE) and WP 4 (NEXT GENERATION FACILITY)
4. Validate the results and findings from simulation modelling with the real system. This can be done by multi-expert
workshops and comparisons with historical data
Cranfield University will be involved across the WPs. Furthermore, WP 2 will be contributing to other WPs as covered
below:
1. Based on the scope of work defined in WP1 (ASSESSMENT OF CURRENT MANUAL SYSTEMS), Cranfield University
will work closely with the Cell Therapy Catapult and others to collaboratively
conduct the review and gain knowledge from WP1
2. WP3 to provide relevant data required to develop simulation models (e.g. type of automation, degree of automation,
cost of automation)
3. WP4 to provide relevant data required to design the proposed production system
4. Specific outputs to WP3 include various Decision making toolsets to identify where and how automation can be applied,
what time and cost savings can be achieved through automation, what is the future supply chain going to look like. Case
reports for industrial validations demonstrating the benefits of automation strategy using simulation modelling.
5. Specific outputs to WP4 include optimised process configurations for FBS manufacturing supply chains
6. From time to time the project partners need to validate the model developed and provide feedback. Validation to happen in 2 stages:
a. To check of the model developed confirms to the real system (to be done by FBS)
b. To check if the results from simulations are consistent with the initial assessment and meets the targets (to be done by
FBS and Cell Therapy Catapult)

The aim of this industry-led project is to develop and implement novel rapid prototyping and manufacturing capability at
Fisher Bioservices in order to support with drastically increasing the manufacturing scale. Impact and working with
beneficiaries is embedded in the project; not a separate event after completion. That means that throughout the project all
partners are committed and contribute their skills and experience to achieving our common aims and objectives.
Beneficiaries will include all partners who are involved in this project. However, FBS will directly benefit from process
optimisation through simulation modelling in terms of reducing their lead time to manufacture and supply critical products
but also substantially reduce the cost associated with resources, rejections, losses etc. Given the benefits of simulation, the
adoption of simulation-based studies in the biopharmaceutical sector is limited when compared to other manufacturing
sectors. This has created a huge gap in the current market to utilise simulation modelling techniques for designing
biopharmaceutical manufacturing processes (Saraph, Prasad V. "Future of simulation in biotechnology industry."
Simulation Conference, 2004. Proceedings of the 2004 Winter. Vol. 2. IEEE, 2004.). As early adopters of these techniques
to innovate their workflows, FBS can further gain significant competitive advantage and set standards as world leaders in
Cell Therapy manufacturing and supply chain. Additionally, significant value can be added through dissemination of the
knowledge and results from this project. Cranfield University along with other industrial partners will develop a number of
relevant courses and events targeted at university students and industry executives. Furthermore, the results will be
presented in international journals and conferences to maximise the dissemination impact. Cranfield University will also
benefit from the establishment of this relatively new research area allowing future collaboration with other research groups
both within and outside the university.
An effective multi-disciplinary approach is needed for the project to be successful. This requires intensive communication
across disciplines and organisations. Cranfield plans to set up a web-based communication portal to enable effective
engagement of all project partners. Furthermore it is important that we develop a dialogue with stakeholders and
beneficiaries. Findings and outcomes at key stages in the project will be shared using the portal and social networking
media.
Cranfield will ensure that clinicians and patient will be involved with other stakeholders throughout the project. The PI has
already been able to identify and involve NHS partners in the preparation of this proposal. We will apply co-creation and codesigning
simulation and modelling methods to ensure that the rapid prototyping and manufacturing system delivers
products than can be processed by supply chain partners, used by clinicians and will be accepted by patients. Only this
approach will lead to fast adoption and diffusion and will ultimately ensure the commercial success of the approach.
This programme of multi-disciplinary research will provide a model for translating scientific
discoveries into clinical and commercial solutions. Knowledge transfer is an ongoing Impact
affecting each of the phases in the work plan. The project will offer case studies of production systems and supply chains
that are potentially applicable to other areas in the pharmaceutical sector. This will be disseminated through:
1. Developing and maintaining a project web-portal
2. Publishing articles and papers
3. Organising and participating in events such as seminars and conferences
4. Delivering education programmes
5. Developing further applied research activities in pharmaceutical product development