Process Development is a critical aspect of product development that aims to reduce the costs, risks and timelines for projects entering GMP manufacture.
Our Process Development team will:
Process development studies can involve:
Upstream process development studies involve optimising the multiplicity of infection and point of harvest for optimum viral replication and amplification within GMP compliant cell lines.
After harvest and lysis, the clarification steps are optimised for benzonase and/or other treatment.
Downstream process development studies involve optimising the purification steps to improve product yield and decrease product losses.
Process development can optimise assays to improve process knowledge. Process development can also qualify assays to ensure that assays used for product release testing are accurate, precise and reproducible.
Process development can evaluate the stability of adenoviral vector products at a range of monitored temperatures at different stages during processing. Stability testing of final purified product is performed by QC.