We bring extensive experience in stabilizing conjugated biologics across a wide range of payload classes and linker technologies. Our team develops both liquid and lyophilized formulations tailored to your ADC’s specific characteristics. We integrate:
● Molecular Modeling of protein, and drug conjugated protein to evaluate change of characteristics
● Holistic analytical characterization (antibody, linker, payload).
● Stability profiling across stress conditions.
● Formulation design to minimize degradation and aggregation.
● Robust formulation pathways aligned with target product profile.
Key Focus Areas
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1. Feasibility assessment: Molecular modeling and molecule characterization, risk identification, and early excipient strategy.
2. Formulation optimization: iterative DoE for stability, potency preservation, and manufacturability.
3. Stability programs: ICH Q1-aligned long-term accelerated and forced degradation studies.
4. Handling and scale-up: safe OEB 5 processes and Fill&Finish ready formulation packages.