Our Approach
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 programs. A product specific analytical testing program will be designed and assays qualified to ensure product quality is prioritized.
Our goal is to enhance your product development pipeline by providing expert advice and access to an integrated pipeline of services including:
- Recommendations for process improvement and optimization
- Qualification of appropriate analytical assays to evaluate safety, identity and purity
- Protocol translation to a production method capable of GMP manufacture
- Scale-up and automation assessments
- Generation of test articles for pre-clinical and toxicology studies
We recognise that the development of robust and reproducible production methods becomes increasingly important as the product advances through clinical trials towards successful commercialization. Process development strategies can be implemented to gain efficiency while maintaining optimal safety and quality profiles. The identification of the key product attributes is summarized in the target product profile and considerations for process optimization are formulated to ensure success.
Science-Driven
