Advanced Therapies (or Regenerative Medicines) including cell, gene and tissue engineered products are an emerging class of living medicines. Despite their curative potential – they are currently prohibitively expensive to patients, labour intensive to produce and complex to develop. To move these therapies into mainstream usage the field is turning to technology.
Challenges in Cell and Gene Therapy
The Synthace Solution
Improve Product Quality and Quantity
Autologous cell therapy products are made on a patient-to-patient basis, with methods often developed on healthy donor material. A deep understanding of production parameters methods is needed to define representative critical quality attributes (CQAs) and create robust scaled-out processes.
Automated DoE allows full exploration of process and product parameters.
Our platform dramatically reduces the planning and execution time of complex, multi-factorial experiments, making insight-rich experiments such as DOE routine. Digitally defined methods also accelerate and standardise tech transfer from process dev to manufacturing and from biotech company to CDMO.
87% of CGT companies think reducing the high CoGs is important. Reducing the labour investment into many manual processes such as QC is essential for increasing facility usage, reducing human error and thus reducing cost
Automation allows for 24/7, 365 facility operation.
Liquid handling automation, coupled enhanced sample traceability and analytics integration closes the loop, reducing human intervention and increasing throughput.
Tools are needed that enable a data science approach to process optimisation and manufacturing.
To robustly and cost-effectively scale-up or scale-out CGT products requires a deeper understanding of the experimental design space, as well as use of technologies that can adapt to manufacturing variances in real-time.
Automated experimentation enables machine learning.
Process development methods such as PAT (process analytical technology) and DOE are routinely used in CMC and manufacturing, but both generate huge data streams. Our platform works with existing hardware to produce structured data sets; enabling machine learning for advanced process optimisation or adaptive manufacturing.
Suggested applications in Cell and Gene Therapy
Optimisation of growth media to increase AAV or lentiviral titre
qPCR automation for higher throughput QC testing in autologous cell therapy
Transfection and transduction protocol refinement
Media optimisation for cell expansion and differentiation
Rapid in-house DNA assembly to create CAR libraries