Monoclonal antibodies are important tools for treating numerous diseases such as cancer, autoimmune, and inflammatory conditions. As of 2018, over 80 monoclonal antibody drugs have been approved for clinical use by the FDA (Food and Drug Administration, USA) and the EMA (European Medicines Agency, EU). Key steps in the development of therapeutic antibodies are the optimization of their short- and long-term stability, as well as preformulation and final formulation conditions.
The FORMOscreen® is an antibody formulation screen compatible with biophysical and biochemical read-out (e.g. DSF, nanoDSF, DSC, DLS, SLS, LC-MS, HPLC-SEC, ELISA,...) allowing for quick and easy analysis of important antibody parameters: Chemical, thermal, colloidal, and conformational stability, long-term storage stability, forced-degradation resistance, as well as biochemical activity and antigen-binding.
The FORMOscreen® conditions, derived from the formulations of therapeutic antibodies approved by the FDA and EMA, have already shown to have positive effects on antibody formulation and stability and thus provide optimal starting points for developing preformulations for therapeutic and diagnostic antibody candidates.