One of our most critical differentiators is the unmatched flexibility of our technical platform solutions and the range of technologies we use. Together we can conduct side-by-side comparisons of your platform operations with ours to ensure the best aspects are carried forward. Optimization of the process is then achieved using design of experiment (DoE) methodology. These services are specialized for AAV processes.
Process design
Process feasibility
Upstream and/or downstream process development
Assay development and qualification
Master and working cell and virus banks
Scale-up and engineering run(s)
GMP bulk drug substance
GMP aseptic fill/finish
Analytical lot release testing
ICH stability testing
Chemistry, manufacturing and controls support
