Affilin® molecules are drugableData obtained with the Affilin® scaffold support outstanding characteristics for the development of novel therapeutics:
CMC requirements:- Affilin® scaffold is stable at high temperatures (90 °C).
- Affilin® scaffold is pH stable.
- Affilin® scaffold unfolds and refolds readily in solution.
- Affilin® scaffold resists degradation in intestinal fluid.
- Affilin® scaffold is stable in rat serum for days.
- Affilin® scaffold has an extreme long shelf life at room temperature and 4 °C (months).
- Affilin® scaffold is soluble and has no aggregation potential.
Safety and toxicity requirements:- Affilin® scaffold can be administered i.v. and s.c.
- Affilin® scaffold shows very good biodistribution and elimination.
- Affilin® scaffold shows no adverse effects in a 14-day sub-chronic toxicology study.
- Affilin® scaffold provoked no signs of inflammation during a 3 month study. Also no general immuno suppressive effect has been observed.