Let's talk about a feasibility program designed to help you make an informed decision
Maximum Flexibility with a Variety of Options
You have a choice when it comes to expression of your drug candidate – and this choice can have significant long term commercial impact. The expression host can affect many aspects of your therapeutic including titer, post translational modifications, biological function, future manufacturing process and cost of goods.
Beginning with the end in mind and investing time at an early stage, can facilitate a smooth transition from clinical to commercial manufacture and set the stage for commercial viability of your drug candidate.
Our Feasibility Program has been designed with maximum flexibility and a variety of options so you get the specific information and proof of concept material you need – when you need it.
Primary Screen
6 to 7 weeks
- Identifies optimum host, initial titer and critical product quality attributes
- Delivers GMP compliant research cell bank
- Next step options: Move on to secondary screening for further optimization of strain or move forward with REA to work in your own lab
Secondary Screen
3 weeks
- 12 best clones run in fed batch mode in minibioreactors
- Optimized titer and critical product quality attributes
- Delivers Biomass or culture supernatant
- Next step options: Lonza can supply PoC material or move forward in your own lab
Proof of Concept Material Supply
4 weeks
- Choice of material supply: 250mL, 2L or 20L bioreactors
- Downstream purification with two chromatography steps
- PoC material generated for in house testing
- Final information includes analytics on critical quality attributes
Ready to accelerate your drug development program?