Our approach to process optimisation is built on a strong technical background in cell biology, cell culture, scale-up and product characterisation.
We are inspired by a passion for cell therapy development and will work with you to design a production method capable of GMP-compliant manufacturing to meet the stringent regulatory standards required.
Our dedicated team of cell therapy development scientists will assess your process and work with you to develop production methods to meet the requirements of your clinical programmes. We have experience in scaling up a wide variety of cell types in systems from small scale culture wells to flasks to cell culture bags to cell factories and on to automated cell culture systems. Irrespective of scale, your manufacturing process will be designed to ensure that the critical control points are identified and monitored to ensure the product maintains its critical quality attributes. A product specific analytical testing programme will be designed and assays qualified to ensure product quality is prioritised.
It is our goal to de-risk your product development pipeline by providing expert advice and access to an integrated pipeline of services including:
- Recommendations for process improvement and optimisation
- Qualification of appropriate analytical assays to evaluate safety, identity and purity
- Protocol translation to a production method capable of GMP manufacture
- Cryoformulation and cryopreservation studies
- Scale-up and automation assessments
- Generation of test articles for pre-clinical and toxicology studies
At RoslinCT we recognise that the development of robust and reproducible production methods becomes increasingly important as the product advances through clinical trials towards successful commercialisation. Process development strategies can be implemented to gain efficiency while maintaining optimal safety and quality profiles. The identification of the key product attributes is summarised in the target product profile and considerations for process optimisation are formulated to ensure success.