Developability, Stability, and Biophysical Assessment
Manufacturability assessment assesses a lead biologic candidate for efficient and large-scale biomanufacturing, resulting in a stable and efficacious drug for clinical use. The process involves the ability to be concentrated, evaluation of stability and propensity to aggregate under different conditions. The biophysical and biochemical properties of lead biologics are important for ensuring the drug can be manufactured, stored and transported at a consistent quality, efficacy, and safety. This mitigates the downstream risk of encountering issues during manufacturing scale-up and ensures that the biotherapeutic meets regulatory requirements.
More Confident Lead Selection and Formulation
Eurofins Discovery can help you assess the biophysical characteristics of your lead biotherapeutics candidates, including ADCs. Our experts can screen for stability over time, temperature and pH and perform forced degradation studies. We also have high-throughput buffer exchange capabilities for optimizing and determining the best shipping, storage, and usage conditions.
Developability and CMC Assessment
Developability and CMC assessments evaluate a lead candidate’s biophysical characteristics, manufacturing processes, and quality controls, respectively. These analyses are essential for mitigating risk of material loss or degradation, quality assurance, managing efficient use of resources, and assessing the overall manufacturability of a lead biologic. This enhances the likelihood that a biologic will successfully be brought to market. Our experienced team offers comprehensive manufacturability assessment for various biologics, including monoclonal antibodies, ADCs, and more.
Stability and Forced Degradation
Assessing biologics stability is critical for ensuring a drug maintains appropriate conformation and quality throughout manufacturing, transport, storage, and usage. Stability and forced degradation testing help optimize formulation, accurate shelf-life determination, and lead selection, supporting the successful commercialization of your therapeutic. We perform stability, forced degradation studies, and pH stability to help you establish different formulation conditions, concentration, shipping and storage requirements to determine your lead candidate’s shelf-life and re-test time points. Our specialized instruments enable testing with less material than traditional methods, and our protein production team can help you perform pilot or large-scale expression for comprehensive stability testing.
Biophysical Characterization
Biophysical characterization involves the structural and functional assessment of a lead biotherapeutic candidate. The results guide formulation, detect aggregation, and help support quality control. Eurofins Discovery can accurately determine melting and aggregation temperature and measure aggregation under multiple conditions, including different concentrations, buffers, and times.
