Cell and gene therapy scale-up
Cell and gene therapies have huge potential for the treatment of a range of human diseases. If their benefits are to be fully realized, however, their production must scale for commercial manufacture. At the heart of this challenge is the need to design an automated, repeatable and compliant process for generating therapeutic quantities of cells.
At Sagentia, we are highly experienced in developing automated, commercial and large-scale manufacturing processes applicable to cell and gene therapies. Our scientists work at the leading edges of biology, fluidics, engineering and process control to offer:-
- Scale-up: complex system design and development
- In-line sensing: Cell identification, expression, and expansion diagnostics including apheresis and TCR proteins
- Traditional and advanced sensing techniques: Imaging, optical biosensors, flow cytometry, quartz crystal microbalance
- Smart automation for high-throughput commercial applications
- Electromechanical integration
- ISO and IEC regulatory compliance and Good Manufacturing Practice (GMP)
Sagentia’s work in automated manufacturing systems and scale-up for continuous manufacture includes:-
- Taking novel lab-scale manufacturing processes to scale-up to full GMP pilot lines for use in clinical trials
- Deciphering complex physics issues which were preventing scale up to a production device and delivering a process to manufacturing tolerances
- Scale-up of microfluidic processes for drug production
- Redesign, simplification and production cost reduction
- Function enhancement via use of microfluidic geometries
Complete our contact form for an informal chat with one of our medical technology consultants.