The formulation antibodies has a profound impact on their thermal, colloidal, and chemical stability. We recognize the importance of addressing these factors early in development to set you up for success. Understanding how buffer components and conditions influence stability isn’t just about better data; it’s about smarter assay design and more accurate interpretations. We employ statistically-driven design of experiments (DoE) to navigate the complex interplay of variables, empowering you to make informed decisions at every stage: Whether preparing for IND studies, optimizing downstream processes (DSP), or rigorously testing stability under stress conditions. Our expertise in antibody development is your assurance.
What 2bind can do for you
Antibody developability and formulation team assembly
Antibody-specific research (a priori data analysis, structural analysis, etc.)
Parameter and deliverable definition for the developability study
Selection of suitable technologies
Pre-formulation assay cascade definition
Access and sourcing of material
Antibody and reagent qualification
Instrument and assay qualification
Technical developability assay parameter establishment
Developability assay and instrument setup
Design of Experiment (DoE) approach to find relevant factors that influence the antibody
Assay format and antibody stress-testing according to requirements
nanoDSF for conformational stability
DLS for colloidal stability and self-interaction propensity
SEC MALS for size determination and colloidal stability
HIC for hydrophobic profiling
IEX for charge profiling
Computational expert statistical analysis to derive relevant factors
Use the 2bind FORMOscreen® Antibody Formulation Screen for a more crude approach
Use the 2bind KOMBOscreen® Antibody Formulation Screen for a more targeted approach
Response Surface Methodology (RSM) approach to find quadratic relations between chosen factors
Assay format and antibody stress-testing according to requirements
nanoDSF for conformational stability
DLS for colloidal stability and self-interaction propensity
SEC MALS for size determination and colloidal stability
HIC for hydrophobic profiling
IEX for charge profiling
Computational expert statistical analysis to derive optimal conditions
Analytical verification of computer-supported determination of formulation conditions
Referencing and comparative analysis of conditions
Assay format and antibody stress-testing under developed conditions
DLS for colloidal stability and self-interaction propensity
SEC MALS for size determination and colloidal stability
HIC for hydrophobic profiling
IEX for charge profiling
What 2bind delivers for Antibody Developability and Pre-formulation
