Developability Assessment

Dr. Anne Zeck
Group Leader Bioanalytics

+49 7121 51530-811

E-Mail

anzeigen

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 HPLCL-MS/MS
• Relative quantification of degradation hot spots