Developability Assessment

Dr. Anne Zeck
BioDevCenter
Senior Principal Scientist

Development and stability studies of recombinant proteins (antibodies)

Testing the developability of a potential biotherapeutic is essential to its successful manufacture and storage. Testing includes in-silico evaluation of the primary amino acid sequence, storage under various pH conditions, and biochemical and biophysical methods to test the chemical and structural stability of the molecule.

 

Our services

  • In silico developability assessment for potential deamidation, succinimide formation, autohydrolysis, oxidation
  • Stability-degradation studies

 

Methods

  • In silico analysis
  • Tryptic PeptideMap with HPLC-MS/MS
  • Relative quantification of degradation hot spots

 

Publication

Kaiser , P. et al.: Developability Evaluation of Single-Domain Antibody-Chelator Conjugates for Diagnostic Radiotracers. Antibodies 2026, 15, 22. https://doi.org/10.3390/antib15020022