Non-invasive Image Analysis for Process Analytical Technology (PAT) Approaches to Cell Based Therapy Manufacturing
PhD Supervisor(s): Rob Thomas, David Williams
Contact Email:d.smith4@lboro.ac.uk
Undergraduate Degree: MEng Biochemical Engineering (University of Bath)
PhD Summary
Process development requires a structured and systematic approach, particularly given the complexity of human therapeutic cell culture, and this ethos is reflected in frameworks such as six-sigma and ISO publications. Conventional pharmaceutical and biologics production has begun to embrace the concept of Quality by Design (QbD) to reduce the risk associated with poorly developed processes. A QbD production process is one that has been systematically engineered to have a defined operating space. This enables appropriate process controls to be implemented at critical points and effective risk management.
A major limitation on process development using QBD or similar methods is the lack of non-invasive and label free measurements of process performance. The Cell-IQ by Chipman Technologies is a state of the art system for real time quantitative assessment of changes in cell cultures through processing phase contrast images. However, to be useful in manufacturing monitoring or process development we need to understand how quantitative parameters extracted from label-free images relate to cell quality. This project aims to measure quantitative metrics derived from image analysis and utilise these traits to make process decisions that impact on cell quality.
Skills & Techniques
Publications, Presentations and Awards
Oral Presentations
Travel bursary and Poster Presentations
Poster Presentations
Future/Career Plans
Using my engineering background combined with biological knowledge acquired throughout my PhD I aim to become project manager to oversee regenerative medicine research from an engineering stand point. Alongside my engineering and biological education the regenerative medicine industry provides a fantastic opportunity to yield the next generation of novel products and tools whilst accomplishing commercialisation within the cellular therapies.
