Process Development
Points to consider in developing a biopharmaceutical process include:
protein purity, scale-up requirements, yield, practical manufacturability and overall cost.
A typical process development protocol for recombinant protein includes:
Optimization of Expression System.
- Choice of vector
- Choice of cell line and clonal selections
Optinization of Fermentation Condition.
- Available media and supplements
- Growth parameters including pH, temperature, O2, etc.
Development of a Purification SOP
- Choice of chromatography steps
- Endotoxin removal
- Virus inactivation and clearance
Confirmation by the Customer and Technology Transfer
- Original records
- Quality analysis method
- Quality analysis results
- Final SOP of the purification process
- Delivered product
