Developability Assessment
BioDevCenter
Senior Principal Scientist
Assessment of the Stability, Degradation, and Developability of Biopharmaceutical Proteins
We support you in assessing the stability and developability of your proteins—from early-stage candidates through to process optimization.
Our mass spectrometry and biophysical methods enable the targeted identification of degradation mechanisms, stability risks, and critical process parameters.
Typical questions:
- Is my protein (e.g., antibody) stable enough for manufacturing and storage?
- What chemical and structural changes occur?
- How do pH, temperature, or formulation affect stability?
- What differences exist between batches or variants?
Our Services
Early Assessment of a Protein's Suitability for Development and Production
Services:
- In silico analysis (e.g., deamidation, oxidation, sequence motifs)
- Identification of potential sites of instability
- Evaluation of critical amino acids
Benefits for you:
- Early-stage risk assessment
- Informed decision-making for candidate selection
- Support for protein engineering
Systematic investigation of stability under relevant conditions
Services:
- Storage studies (pH, temperature, time)
- Forced degradation studies
- Comparison of different formulations
Benefits for you:
- Identification of Critical Factors
- Stability Profile of Your Molecule
- Foundation for Formulation Development and Storage Strategies
Detailed molecular characterization of degradation processes
Services:
- Peptide mapping using LC-MS/MS
- Identification of degradation hotspots
- Quantification of chemical modifications (e.g., deamidation, oxidation, fragmentation)
Benefits for you:
- Molecular understanding of stability issues
- Quantitative assessment of degradation processes
- Foundation for targeted optimization
Bewertung von Konsistenz und Veränderungen
Services:
- Batch-to-batch analysis
- Comparison of variants (e.g., mutants, formulations)
- Impact of process changes
Benefits for you:
- Ensuring reproducibility
- Identifying critical differences
- Supporting QC and process development
Typical Applications
Biopharma & Biotech
- Candidate Selection (Lead Selection)
- Developability Assessment
- Process Development and Optimization
CDMOs & Production
- Batch Comparison
- Process Changes
- Stability Studies for Release and Storage
Diagnostics & Life Science
- Stability of Proteins and Reagents
- Comparison of Different Production Strategies
Methods
- LC-MS/MS (peptide mapping)
- Relative quantification of modifications
- In silico analysis of sequence risks
- Biochemical and biophysical stability analyses
Here's what a project with you might look like:
Stability Analysis of a Recombinant Antibody
- Storage under various stress conditions
- Identification of oxidation and deamidation sites using MS
- Quantitative assessment of the changes
Result:
- Identification of critical degradation hotspots
- Optimization of formulations and storage conditions
Why Choose the NMI as a Partner?
- A combination of in silico, mass spectrometry, and biophysical methods
- Experience in the analysis of complex proteins and antibodies
- The interface between research and industrial applications
- Flexible collaboration: from feasibility studies to comprehensive projects
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
NMI Natural and Medical Sciences Institute
at the University of Tübingen
Markwiesenstraße 55, 72770 Reutlingen
Tel.: +49 7121 51530-0
Mail:
info@nmi.de
Follow us now
