Annoucing the first comprehensive characterization data package delivered by NovaBioAssays to support a BLA filing that has been approved by FDA in 2021. Over about two years, we performed extensive analytical and fractionation method development including RPLC, SEC, HIC, CIEF, and IEX. Characterization was performed with intact or fractionated variants for the elucidation of structures, comparability, and forced degradation studies by utilizing hyphenation of various separation modes with an array of detections including HDX MS, peptide mapping, intact MS, SEC-UV-native MS, IEX-UV-native MS.

We have Thermo Orbitrap Exploris 480 Mass Spectrometer and MSD MESO QuickPlex SQ 120 installed and running recently.

We made prolyl endopeptidase enzyme column commercially available for HDX MS, which preferably cleaves at the c-termini of amino acids such as, P, C, A, L etc.