Chemical Stability Assessment
Our company's developability assessment begins with a comprehensive evaluation of chemical stability profiles for candidate molecules. Our experts utilize state-of-the-art analytical techniques, including spectroscopy and chromatography, to identify potential degradation pathways such as hydrolysis, oxidation, deamination, and aggregation. By characterizing these stability profiles, we empower clients to make informed decisions regarding the suitability of drug candidates for further development.
Physical Stability Evaluation
Assessing the physical stability of drug candidates is crucial for ensuring long-term efficacy and viability. Our company employs rigorous methodologies to evaluate factors such as polymorphism, particle size distribution, and moisture content. These assessments provide valuable insights into the physical behavior of molecules under varying conditions, guiding formulation strategies and optimizing product stability.
Colloidal Stability Analysis
For formulations involving colloidal systems such as nanoparticles or liposomes, understanding colloidal stability is paramount. Our company employs specialized techniques like dynamic light scattering (DLS) and zeta potential analysis to evaluate colloidal stability, optimizing formulation design and drug delivery outcomes.
Physicochemical Properties Profiling
Early characterization of physicochemical properties such as solubility, viscosity, and crystallinity provides critical insights into formulation development and dosing strategies. Our comprehensive assessments guide clients in designing dosage forms tailored to specific therapeutic needs.
Fit for Upstream and Downstream Processes
Our company's developability assessment extends beyond molecular properties to evaluate compatibility with upstream cell culture processes and downstream purification processes. Our holistic approach ensures seamless integration into manufacturing workflows, minimizing risks associated with scale-up challenges and optimizing process efficiencies.
