Our approach to process development is built on a strong technical background in cell biology, cell culture, bioprocessing, and assay development.
Our dedicated team of Cell Therapy Development Scientists is here to assist and aid you all the way from your scientific idea to the manufacture of a commercially feasible cell-based product.
We are experienced and well-versed in all aspects of cGMP process development and translation. We will advise and support you in choosing the most optimal cell culture system, from small scale culture wells to flasks to cell culture bags to cell factories and bioreactors.
Irrespective of scale, your manufacturing process will be designed to ensure product quality and integrity. Critical quality attributes of your product will be monitored via a product-specific analytical strategy, which we will design, develop and validate for you.
It is our goal to de-risk your product development process by providing expert advice and access to an integrated suite of services:
- Process Gap Analysis to evaluate commercial- and/or GMP-readiness of your process
- Process development and optimisation (includes, but not limited to scale-up, scale-out, automatisation and cryoformulation)
- Development and validation of appropriate analytical assays to evaluate potency, identity, purity and safety of your product
- Translation of procedures and associated documentation to ensure GMP-compliance
To ensure effective communication and timely progress of the project, we will appoint a Project Manager, who will be working closely together with you during the lifecycle of the project.
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. We are here to support you during this journey creating a robust manufacturing process from the onset of your project.