Process Science Development
Process Screening & Optimisation
The Process Science team has the expertise and experience in establishing processes for seamless biomanufacturing. The development starts with the selection of process strategy with three major operations namely cell culture development; separation and filtration; and purification.
Cell Culture Development
- Cell culture development using different modes of bioreactor operation such as batch, fed-batch or perfusion strategy
- Perfusion study using external spin filter technology
- Physical parameter optimisation
Separation and Filtration
- Process development using various modes of operation; dead-end filter or tangential flow filtration through membrane cassette or hollow fibre configuration
- Virus filtration using various filter types and configuration
- Virus inactivation by means of heat and chemical treatment
- Process parameter optimisation
- Development of a purification strategy and chromatographic sequence to achieve the specific recovery and final purity requirements
- Wide range of chromatography media screening in every step of chromatography
- Parameter optimization in every step of chromatography to achieve the highest recovery and purity
Process Scale-Up and Technology Transfer
The process scale-up operation will involve:
- Cell culture scale-up from the bench top bioreactor to pilot scale (up to 100 litre).
- Pilot scale filtration system for cell separation and product concentration operations.
- Purification scale-up activities using pilot chromatography system and column with larger diameter, based on capacity calculation.